Regulatory Affairs Specialist Resume Sample
Allen Hermann
83035 Brigitte Gateway,
Detroit,
MI
+1 (555) 727 0710
Work Experience
Regulatory Affairs Specialist
05/2018
-
PRESENT
Houston, TX
- Connect by encouraging and supporting internal collaboration across levels, creating effective solutions. Builds and leverages internal and external networks with colleagues, cross-functional partners, and industry contacts to identify opportunities and open communication channels
- Shape by challenging the status quo and adapting to change, taking advantage of opportunities to have a positive impact. Engages with local and/or regional regulatory agencies, industry groups, standards committees, political/government agencies, in order to influence external stakeholders and promote Regulatory perspectives
- Lead by leveraging diverse perspectives, backgrounds and talent to generate effective ideas or solutions
- Deliver by acting with speed, flexibility , accountability and appropriately managing priorities to deliver results for on-time clearances
- Coordinates resources to ensure the ongoing effectiveness of the compliance program, which includes organizing and maintaining relevant files and preparing necessary reports on activities
- Conducts independent research on assigned projects and collaborates and coordinates with other other departments on information needs
- Monitors compliance with laws, rules, and regulations, as well as Health Plan policy
- Researches regulations, inform various departments of regulations, and assist as needed in developing procedures to comply, as well as draft responses to queries by regulatory agencies
- Coordinates the filing of regulatory forms, reports, etc. Assists other departments in understanding and complying with regulatory requirements to include researching regulations, informing departments of regulations, and assisting as needed in developing procedures to comply with, and draft responses to queries by regulatory agencies
Senior Regulatory Affairs Specialist
10/2013
-
01/2018
Phoenix, AZ
- Develops and maintains productive relationships with all levels of management as well as regulators and other relevant external parties
- Supports the design and implementation of databases to ensure key departmental processes are captured in the database for tracking and trending purposes
- Profound knowledge of regulatory requirements for Medical Devices and Drugs
- Persuasive communicate and influence regulators and other key stakeholders
- Highly skilled in establishing partnerships and collaboration with business partners, Franchise RA and regional RA, as well as other stakeholders
- Strong results-orientation and sense of urgency
- Solid capacity to analyze, interpret and synthesize on regulation and guidelines
- Strong capability of self-awareness and adaptability
- Live the credo in a way that creates a trusting, collaboratively and ethical work environment
Associate Regulatory Affairs Specialist
10/2010
-
08/2013
Los Angeles, CA
- Connect by cultivating external relationships with regulators and internally collaborating
- Shape by anticipating and influencing regulatory changes and maximize patient access to innovative technologies
- Participate in product development/line extension teams as required to ensure that the product is in compliance with all internal and external regulatory requirements. Develop, document and implement regulatory submission plans around product development/line extension goals
- Drive Labeling and Copy review for Lutonix products for domestic and International markets
- Prepares and updates European and International technical files/dossiers/registrations as required and per applicable SOPs
- Prepares U.S. FDA submissions (e.g., IDE, PMA, annual reports) as required and per applicable SOPs
- Reviews Engineering Change Orders, Design Change Notices and other deviations for compliance with FDA, European and International regulations and standards
- Ensure adequate documentation of Bard Lutonix compliance to FDA, European and International regulations and standards. Ensure Regulatory Affairs files are updated and maintained as required
Education
Fairleigh Dickinson University - Metropolitan Campus
2006 - 2010
Bachelor's Degree in Science
Professional Skills
- Demonstrated excellence in the following: communications skill, listening skills, interpersonal skills, planning, research, diplomacy, and advocacy skills
- Strong negotiation skills, written/oral communication skills and interpersonal/teamwork skills
- Demonstrated self-starter, learning agility, with multi-tasking skills, problem solving and prioritization skills
- + Demonstrated project management skills; Excellent organizational and problem solving skills
- Demonstrated project management skills; Excellent organizational and problem solving skills
- Excellent Interpersonal Skills and strong virtual communication skills (e.g. telephone. Electronic media)
- + Excellent communication and interpersonal skills. Strong negotiation / resolution skills
How to write Regulatory Affairs Specialist Resume
Regulatory Affairs Specialist role is responsible for interpersonal, organizational, computer, analytical, technical, english, regulatory, organization, microsoft, presentation.
To write great resume for regulatory affairs specialist job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Regulatory Affairs Specialist Resume
The section contact information is important in your regulatory affairs specialist resume. The recruiter has to be able to contact you ASAP if they like to offer you the job. This is why you need to provide your:
- First and last name
- Telephone number
Work Experience in Your Regulatory Affairs Specialist Resume
The section work experience is an essential part of your regulatory affairs specialist resume. It’s the one thing the recruiter really cares about and pays the most attention to.
This section, however, is not just a list of your previous regulatory affairs specialist responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular regulatory affairs specialist position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Regulatory Affairs Specialist resume experience can include:
- Excellent communication skills (verbal and written) and good interpersonal skills with customer-oriented focus
- Exhibits a thorough understanding of medical device development, strong management skills and long term planning skills
- Demonstrated attention to detail with strong prioritization and organizational skills to ensure deadlines are met
- Excellent interpersonal and organizational skills, maintaining effective working relationships within regulatory groups
- Strong demonstrated written, verbal and interpersonal communication skills
- Demonstrated ability to be flexible with work schedule and strong time management skills
Education on a Regulatory Affairs Specialist Resume
Make sure to make education a priority on your regulatory affairs specialist resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your regulatory affairs specialist experience. For example, if you have a Ph.D in Neuroscience and a Master's in the same sphere, just list your Ph.D. Besides the doctorate, Master’s degrees go next, followed by Bachelor’s and finally, Associate’s degree.
Additional details to include:
- School you graduated from
- Major/ minor
- Year of graduation
- Location of school
These are the four additional pieces of information you should mention when listing your education on your resume.
Professional Skills in Regulatory Affairs Specialist Resume
When listing skills on your regulatory affairs specialist resume, remember always to be honest about your level of ability. Include the Skills section after experience.
Present the most important skills in your resume, there's a list of typical regulatory affairs specialist skills:
- Excellent verbal and written communications skills; strong attention to detail and excellent organization skills
- Interpersonal skills and strong relationship management skills critical to success
- Strong interpersonal and written/verbal communication skills and presentation skills
- Strong negotiation skills and written/oral communication skills
- Strong communication skills and a demonstrated ability to work collaboratively with multiple disciplines, functions and organizations
- Solid and proven project management skills
List of Typical Experience For a Regulatory Affairs Specialist Resume
1
Experience For Senior Regulatory Affairs Specialist Resume
- Excellent teamwork skills and the ability to interface effectively with a wide range of stakeholders
- Organization skills with excellent attention-to-detail skills
- Strong project management and organizational skills with experience working in cross-functional, international, and/or matrixed organizations
- Utilize time management skills to effectively write, coordinate, and execute regulatory items
- Comprehend principles of engineering, physiology and medical device use. Good analytical thinking skills
- Work effectively in a team environment with shifting priorities and timeliness requirements
2
Experience For Principal Regulatory Affairs Specialist Resume
- Possesses excellent interpersonal, analytic, and problem-solving skills
- Profound computer skills (experiences working with database)
- Good interpersonal skills that involves working well in a team environment and the ability to lead others
- Demonstrates both creative and critical thinking skills
- Strong writing, communication (written and oral), analysis, negotiation, time management and project management skills
- Problem solving skills and the ability to appropriately evaluate a situation and prioritize factors for decision making
3
Experience For Associate Regulatory Affairs Specialist Resume
- Demonstrated ability to work effectively in a team environment but as well as individually
- 5) Strong Negotiation skills
- Excellent analytical and math skills to determine trends in chemistry and processing and suggest recommended improvements
- Able to juggle multiple priorities effectively and complete accurately within timeframes
- + Good project management skills
- + Detail oriented and good program management skills
4
Experience For Regulatory Affairs Specialist Device & Diagnostics Resume
- Excellent team skills with ability to influence others
- Demonstrated high performance orientation, detail orientation and organization skills
- Effective verbal and written communication skills in English in a cross functional environment
- Good negotiation and diplomatic skills, capacity to work in an international environment
- Strong command of communication and presentation skills
- Able to effectively operate in a cost-conscious environment
- Strong time management skills, with the ability to work on multiple projects simultaneously
- Excellent communication skills across the stakeholder spectrum
5
Experience For Senior Regulatory Affairs Specialist Device & Diagnostics Resume
- Good communication skills (collaborative approach), open-minded000019QM
- Demonstrated organizational, time management, and project management skills
- Strong oral and written communication skills with the ability to listen, articulate, and advocate to diverse audiences
- + Abilityto effectively manage multiple projects and priorities
- + DemonstratedMicrosoft Word, Excel, Office, PowerPoint, and Adobe software skills
6
Experience For Product Safety & Regulatory Affairs Specialist Resume
- + Effectiveinterpersonal/communication skills
- Proven ability to lead and work effectively in cross-functional teams
- Plan multiple tasks and effectively prioritize activities
- Good organization, interpersonal and judgment skills to influence many diverse internal/external customer groups
- Self-motivated with the ability to effectively manage and prioritize multiple complex tasks
- Planning, organising and time management skills
- Able to apply independent decision making and analytical thinking skills
7
Experience For Associate Regulatory Affairs Specialist Mena Resume
- Computer skills, including MS Word, MS Excel, flow charts, and obtaining information from mainframe databases, such as AS400
- Demonstrated creative thinking and effective strategic planning and facilitation abilities
- Word processing skills, including Microsoft Word, Excel, Access or comparable software
- Technical writing skills and be proficient at compiling successful submissions for the appropriate audience
- Experience, preferably in the medical device industry or related field experience (e.g., hospital / clinical setting, laboratory setting)
- Prior experience in an auditing position or quality systems position is beneficial
- Experience managing multiple tasks and priorities in order to meet assigned due dates
- Building relationships between Regulatory Affairs and other areas of the organization; ability to communicate effectively at all levels
8
Experience For Senior Quality Assurance & Regulatory Affairs Specialist Resume
- + Proven experience leading onshore and offshore cross discipline teams
- Demonstrated experience supporting U.S.FDA regulated product development efforts
- Support cross-training opportunities and skills
- Well-organized & focused. Strategic planning skills
- Strong business process/consulting experience in a Pharmaceutical, Science, or Research & Development function
- Prior experience communicating with state and federal agencies
9
Experience For Principal Quality Assurance Regulatory Affairs Specialist Resume
- Communicate effectively with R&D, Clinical Science and Marketing teams
- Communicate effectively verbally and in writing with diverse audiences and personnel
- Interpersonal, communication and negotiating skills
- Several years of prior regulatory affairs experience and with global understanding of clinical trials
- Prior experience with devices containing software
- Advanced technical writing skills (e.g. regulatory documentation, scientific presentations)
- High communication, inter-personal and relationship-building skills, confident, and credible with both internal and external collaborators
10
Experience For Audit & Regulatory Affairs Specialist Resume
- Expert in Office Computer Skills (Word-processing, spreadsheet, software etc.)
- Demonstrated experience working in cGXP environments
- Demonstrated experience working in New Product Development projects
- Has a balance of strategic planning, analytical skills and ability to execute efficiently
- Prior SAP experience is beneficial
- Proven ability to problem solve, manage & prioritize multiple time-constrained tasks
List of Typical Skills For a Regulatory Affairs Specialist Resume
1
Skills For Senior Regulatory Affairs Specialist Resume
- Skills: Computer skills included be good at using Microsoft office software, AW design software
- + Strong verbal and written communication skills, proven ability to translate technical documentation into effective regulatory submissions
- Effective collaborative and negotiating skills. Experience with cross functional team
- Demonstrated strong writing and communication skills
- Demonstrated ability to balance multiple high priority responsibilities on-time and effectively
- Demonstrates good project management and communication skills
- Excellent organizational skills, strong attention to detail
- Outstanding project management skills by demonstrated competence in managing multiple projects simultaneously is required
2
Skills For Principal Regulatory Affairs Specialist Resume
- Demonstrated organizational and planning skills, including process savvy, action oriented, focused urgency and driving for results
- Strong planning, follow up, reporting and analytical skills to achieve accurate and timely results,
- Be flexible within the Regulatory function to meet the needs of the growing business; using technical expertise, skills, knowledge and experience
- Strong analytical thinking, problem solving and time management skills
- Excellent PC skills, including word processing, spreadsheets
- Good organizational and planning skills; drives for results
3
Skills For Associate Regulatory Affairs Specialist Resume
- Good interpersonal skills that include working well in a team environment and the ability to lead others
- Excellent executive communication and documentation skills to reach audiences with a diverse understanding of technology and tools
- Demonstrated abilities and skills in the following key areas
- Demonstrated communication, presentation, and technical writing skills
- Strong interpersonal, written, oral, communication, organizational and planning skills
4
Skills For Regulatory Affairs Specialist Device & Diagnostics Resume
- Detail oriented to produce accurate and timely results. Strong technical writing skills
- Able to provide leadership and mentoring skills to less experienced regulatory personnel
- Effectively cooperate with Marketing, Category Solutions, Supply teams, Quality Assurance in order to meet annual targets and objectives
- Excellent written and oral communication and technical writing skills
- Demonstrated ability to communicate effectively both verbally and and in writing
- Proven analytical and problem solving skills and the ability to transfer findings into report and presentation formats
5
Skills For Senior Regulatory Affairs Specialist Device & Diagnostics Resume
- + Documented evidence of writing skills
- Strong communication skills (verbal and technical writing)
- Effective technical writing skills for design change documentation
- Excellent communication skills including English language proficiency
- Fluent in French and English, with excellent writing skills
6
Skills For Product Safety & Regulatory Affairs Specialist Resume
- Demonstrated persuasion and consensus building skills
- Sound judgment, strong communication and negotiating skills
- Work independently and have good time management skills
- Professional communication skills and Excellent ability to work in cross-functional environments
- Strong writing skills and ability to use appropriate software tools to develop and edit documents for registration purposes
- Strong organizational and analytical thinking skills. Ability to multitask and meet deadlines
7
Skills For Associate Regulatory Affairs Specialist Mena Resume
- Strong process orientation and administrative skills required
- Strong computer skills (Excel, Word, Power Point, Share point)
- Strong verbal written and interpersonal communication skills
- Documented evidence of proficient technical written and verbal communication skills
- Strong technical and oral/written communication skills
- Good English and German skills (both written and oral)
- Strong collaborative, consultative and negotiating skills
- Demonstrated Microsoft Word, Excel and Adobe software skills
8
Skills For Senior Quality Assurance & Regulatory Affairs Specialist Resume
- Effective organizational skills with an eye for detail
- Exhibit effective/professional written and verbal communication skills required
- Proven computer software skills (Windows Word, Excel, Powerpoint, Project, Outlook)
- Team player with very strong interpersonal skills
- Solid organizational skills, detail oriented
- Exercises independent judgment, ethical behavior, tactful, solid communications skills (written and oral), team player
- Demonstrated computer skills preferably spreadsheets, word processing, database, internet research and other
- Strong communication skills; able to adapt communication appropriately for purpose and audience and able to challenge appropriately
- Strong project management, problem solving, research, analytical skills, and attention to detail
9
Skills For Principal Quality Assurance Regulatory Affairs Specialist Resume
- Methodical with attention to detail and good organizational skills
- High Interpersonal skills, especially clear and effective communication
- Strong verbal and written communication skills and knowledge of interpersonal communication methodologies
- Strong organizational, project management, problem solving, and presentation skills are required
- Language skills: Spanish and Portuguese are strongly desired. Fluent English is essential
- + Good interpersonal skills and able to work well with cross-functional teams
10
Skills For Audit & Regulatory Affairs Specialist Resume
- Very strong computer skills (Excel, power point, etc.)
- Good communication skills, careful to details, initiative, proactive
- Good numerical, analytical and planning skills, together with the ability to take decisions and to translate those decisions into action
- Have good computer skills with working knowledge of Microsoft Excel and Word
- Work accurately with minimal supervision Highly organized/project management skills with the ability to handle conflicting priorities
- Strong project management skills and drive for excellence
- Excellent orgal and written communication skills
List of Typical Responsibilities For a Regulatory Affairs Specialist Resume
1
Responsibilities For Senior Regulatory Affairs Specialist Resume
- Routinely liaise with Quality, Manufacturing, Engineering, Operations, IT, across different Canon entities and other personnel to fully understand the uses of the equipment/device, processes and test method validation, the facility, and computer systems, and write validation documents per regulatory requirements
- Influence and provide guidance to peers and management regarding the importance of the Regulatory Affairs (registration strategy) and associated requirements as they relate to new product development and sustaining engineering activities
- Provide early feedback and guidance regarding product concepts and Design Control decisions. Compile and successfully negotiate clearance or approvals of product registrations with the US FDA and other regulatory authorities
- Effective negotiating skills and demonstrated written/technical skills
- Excellent oral and written communication skills. Excellent organization skills
- Excellent interpersonal skills as well as negotiation skills to resolve complex business situations
- Good team spirit and good communication skills
2
Responsibilities For Principal Regulatory Affairs Specialist Resume
- Strong leadership skills. Demonstrated ability to motivate, influence and gain commitment at all levels of the organization
- + Excellent organizational skills and demonstrated ability to handle multiple tasks accurately and efficiently
- Excellent relationship-building and negotiating skills. Ability to present positions in international forums and defend defined interests
- A strong self starter with well developed skills in negotiating, influencing and project management
- Strong interpersonal, negotiation and problem solving skills
- Works well in a team environment and supports co-workers in a collaborative manner (Good relationship skills)
- Possesses strong interpersonal and persuasive skills
3
Responsibilities For Associate Regulatory Affairs Specialist Resume
- Good command of MS Office (Word, Excel and PowerPoint) skills
- Proven experience and strong understanding of legal compliance environment
- Effectively communicate product priorities with Graphic Artists
- Strong interpersonal, written, oral, communication, organizational, and planning skills are required
- Good computer skills: proficient in Window based software to include Excel and Word
- Excellent organizational, verbal, and written communication skills. Attention to detail required
- Excellent IT skills, especially MS Office and SAP
- Good verbal, written communication skills and the ability to interface with multiple areas
4
Responsibilities For Regulatory Affairs Specialist Device & Diagnostics Resume
- Excellent verbal, written and interpersonal communication skills in English and Dutch, Further EU languages would be advantageous
- Strong decision making skills in ambiguous or unclear situations is required
- Excellent communication, interpersonal skills and ability to promote trust and collaboration
- PC skills: Proficient in Microsoft Office (Excel. Word, PowerPoint, Access), experience with statistical analysis and Minitab
- + Excellent communication skills, both oral and written
- + Prior experience in fast-paced office with multiple priorities
- + Excellent presentations skills
- Excellent verbal and written communication skills in local language– proficiency in written and oral English
5
Responsibilities For Senior Regulatory Affairs Specialist Device & Diagnostics Resume
- Excellent computer skills with a focus on Microsoft Word
- Able to handle multiple tasks/projects and demonstrate flexibility in managing changing priorities
- Experience working with regulatory agencies is required, preferably FDA experience and/or their global counterparts
- + Critical thinking skills
- Advance computer skills using MS Excel, MS Word, or other applications
- Prior experience working with the FDA and international regulators
- Experience: Min.2 years of working experience
6
Responsibilities For Product Safety & Regulatory Affairs Specialist Resume
- Leads the meeting to effectively utilize the time of attendees
- Demonstrates a solid, fundamental understanding of medical terminology, anatomy, regulations, standards and technical concepts
- Possesses appropriate verbal and written communication skills for interacting with internal and external stakeholders
- BSC in Electronics or Biomedical engineering discipline, or equivalent proven experience
- Prior eCTD publishing experience, highly desirable
- Demonstrated strong attitude and work ethic
7
Responsibilities For Associate Regulatory Affairs Specialist Mena Resume
- High interest in technical documentation and precise administrative skills
- 6) Technical system skills (e.g. word processing, spreadsheets, databases, online research)
- 3) Written and Verbal communication skills
- Negotiation skills with regulatory agencies
- Maintain and develop SOP for effectively Quality process implementation
- + Proactive problem solving skills
- Communicate effectively at all levels within Regulatory as well as cross functionally with departments such as R&D, Quality, Manufacturing, and Marketing
- Pronounced project management skills
8
Responsibilities For Senior Quality Assurance & Regulatory Affairs Specialist Resume
- SKILLS AND COMPETANCIES
- Assertive and polished communication skills; well-written and thoroughly researched reports, along with thought provoking oral presentations
- Acute analytical skills and sharp policy interpretation abilities
- Prior experience with eCTD compliant regulatory submissions
- EU/APAC:Prior relevant experience in regulatory affairs or aligned work and in the pharmaceutical or pharmaceutical contract service industry
- Superior organizational skills and very detail oriented
9
Responsibilities For Principal Quality Assurance Regulatory Affairs Specialist Resume
- Proven knowledge of timeshare experience
- Excellent inter-personal, communication and presentation skill
- Detail focused with ability to multitask effectively and work efficiently within a strict timeline-driven environment
- Proven experience working with US FDA, international regulatory agencies on product submissions and registrations
- Regulatory experience and/or experience in the financial services industry is helpful
- Exceptional Interpersonal/Communication skills and the ability to work with all organizational levels
- Skills with Microsoft Word, Excel, and PowerPoint
10
Responsibilities For Audit & Regulatory Affairs Specialist Resume
- Computer skills: knowledge in MS Office (Word, Excel, Powerpoint), Outlook and Sharepoint required
- Computer skills/internet research
- Regulatory Affairs: 2+ years of significant experience in regulatory affairs, or appropriate relevant experience (QA, QC)
- Prior experience with risk management
- Prioritize, multi task, and organize work; project management experience desirable
- Proven ability to develop and execute effective strategies to ensure MDR requirements are satisfied
- + Prior experience with software-driven devices
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