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1+ months

Regulatory Affairs Specialist, Medical Device

Kelly Services
Titusville, NJ 08560
Kelly is currently seeking a Regulatory Affairs Specialist for an on-going opportunity to work for one of the largest well known Global medical device companies in the world.


This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly. This role is full-time and is offering full benefit options. As a Kelly FSP employee you may be eligible for Medical, Dental, Vison, 401K, and a variety of other benefits to choose from. You may also be eligible for paid time off, including holiday, vacation, and sick/personal time.


This position provides direct World Wide Regulatory support to various projects and products within the platform and supports strategic planning and product development efforts and provides Regulatory support for existing products with respect to product changes/modifications.


**RESPONSIBILITIES:**


Ensures compliance with regulatory agency regulations and interpretations.


Prepares responses to regulatory agencies' questions and other correspondence.


Assists with preparing necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides.


Provides solutions to a variety of problems of moderate scope of complexity.


Conducts searches of existing files for requested information.


Maintains and archives all regulatory documentation.


**Functional and Technical Competencies:**


Leverages a working knowledge of the regulatory environment, including compliance, current and proposed laws, regulations and guidance, to prepare compliant Regulatory strategies that are aligned with the business objectives of the company, including consideration of the global regulatory environment.


Executes Regulatory strategies in compliance with relevant laws, regulations, and organizational requirements necessary to obtain, and maintain, legal market status.


Leverages scientific and technical understanding of products under scope of responsibility to provide regulatory input to product lifecycle management and evaluate regulatory impact on products


Effectively manages multiple competing priorities of different functional partners based on factors such as required regulatory submission due dates, time constraints, urgency, and business need


Develops written technical communications that are clear and tailored to the audience and business need (for example, responses to regulators, submission dossiers).


Demonstrates the ability to contribute to the development of effective and results-oriented regulatory strategic plans that are in line with business objectives.


**Qualifications**


Minimum of a B.A. /B.S. within a technical related discipline is required.


Minimum of 3 years of experience in Regulatory Affairs or a Masters degree with equivalent experience.


Ability to work both independently and in a team environment. Ability to problem solve, recognize and find solutions for gaps in processes.


Preferred 510(k) submission and CE-marked Design Dossier and Technical File management experience


International regulatory experience desired


**Why Kelly** **** **?**


Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.


**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)

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Posted: 2021-10-01 Expires: 2021-11-29

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Regulatory Affairs Specialist, Medical Device

Kelly Services
Titusville, NJ 08560

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