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20 days old

Regulatory Affairs Specialist

Kelly Services
Somerville, NJ 08876
Kelly Outsourcing & Consulting Group (KellyOCG), a managed solution provider and business unit of Kelly Services, Inc., is currently seeking a Regulatory Affairs Specialist for a Project engagement at one of our Global clients in Somerville, NJ.


This role is a full-time, fully benefitted position. As a KellyOCG employee you will be eligible for Medical, Dental, 401K and a variety of other benefits to choose from. Youll also be eligible for paid time off, including holiday, vacation and sick/personal time. All KellyOCG employees receive annual performance reviews.


As a Regulatory Affairs Specialist placed with KellyOCG you will be responsible for the following:


**OVERALL 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 Master s 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** **** **?**


The Managed Solutions practice within Kelly Outsourcing and Consulting Group (KellyOCG ) is one focus within the full array of Kelly Services workforce solutions.


Kelly Services has transformed from the staffing industry pioneer to a leading workforce solutions provider. KellyOCG is the distinguished outsourcing and consulting segment of Kelly Services, known for applying a forward-looking approach that enables companies to make strategic workforce planning decisions that impact their business and competitive advantage.


The Managed Solutions practice area of KellyOCG is dedicated to partnering with clients to architect and implement solutions that put them in a position to meet their operational obligation to their organization and freedom to focus on their more strategic business needs.


**AboutKelly Services** ****


As a workforce advocate for over 70 years, we are proud to have a role in managing employment opportunities for more than one million workers around the globe. We employ 550,000 of these individuals directly with the remaining workers engaged through our talent supply chain network of supplier partners. Revenue in 2015 was $5.5 billion. Visit kellyservices.com and connect with us on Facebook (https://www.facebook.com/kellyservices) , LinkedIn (http://www.linkedin.com/company/kellyservices) and Twitter (https://twitter.com/kellyservices) .


Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)
Posted: 2021-10-01 Expires: 2021-11-01

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Regulatory Affairs Specialist

Kelly Services
Somerville, NJ 08876

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