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30 days old

Senior 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_ **_Senior Regulatory Affairs_** **_Specialist_** _for a long-term 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. This is a long term contract (2-5+ years)._





_Please send your resume to Alicia Cali at_ **_alic019@kellyservices.com or call at 216.256.7768._**





_OVERALL RESPONSIBILITIES:_



_The Senior Regulatory Affairs Specialist provides independent regulatory guidance to project teams in strategic planning and related submissions to support client products. Under minimal supervision, the individual leads the US/EU submissions and registrations to allow continued marketing of products in key countries. The Senior Specialist helps to define data and information needed for regulatory actions in conjunction with cross-functional teams. He/she guides conformance with applicable regulations through the development of best practices for Regulatory Affairs processes, procedures and systems._





_POSITION DUTIES & RESPONSIBILITIES:_




+ _Ensures compliance with regulatory agency regulations and interpretations._

+ _Represents Regulatory Affairs on cross-functional project teams._

+ _Provides solutions to a variety of problems of moderate scope and complexity._

+ _Gathers and assembles information necessary for submissions in accordance with regulations and relevant guidelines._

+ _Researches, collects data, and responds to requests from regulatory agencies and/or distributors to prepare and submit documentation for marketing approvals, as well as to provide routine regulatory information to associates and affiliates._

+ _Prepares responses to regulatory agencies' questions and other correspondence._

+ _Prepares regulatory labeling requirements specifications for modified products, and reviews product labeling to ensure compliance._

+ _Provides regulatory guidance to project teams and responds to product information requests._

+ _Provide Regulatory Affairs support during internal and external audits._





**_Functional and Technical Competencies:_**




+ _Leverages scientific and technical understanding of regulated products within scope of responsibility to provide regulatory input to product lifecycle management and evaluate regulatory impact on products (for example, provides Regulatory input into product recall strategies)._

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

+ _Consults with others to understand the benefits, risks, and Credo-based impact associated with decision alternatives before making decisions._

+ _Provides support to complex projects and makes timely and effective decisions based on available information to execute project deliverables. Makes decisions with guidance in ambiguous or unclear situations._





**_EDUCATION & EXPERIENCE REQUIREMENTS:_**




+ _A minimum of a B.A./B.S., preferably within a technical or scientific related discipline, is required._

+ _A minimum of 2-4 years of relevant / regulated industry experience is required._

+ _Experience with medical devices is strongly preferred._

+ _RAC (Regulatory Affairs Certification) by Regulatory Affairs Professional Society, is a plus._





**_important information:_** _This position is recruited for by a remote Kelly office, not your local Kelly branch. Applicants must be legally permitted to work in the United States._



**_Why Kelly?_**




+ _As a Kelly Services employee, you will have access to numerous perks, including:_

+ _Exposure to a variety of career opportunities as a result of our expansive network of client companies_

+ _Career guides, information and tools to help you successfully position yourself throughout every stage of your career_

+ _Access to more than 3,000 online training courses through our Kelly Learning Center_

+ _Weekly pay and service bonus plans_

+ _Group-rate insurance options available immediately upon hire*_





**_Apply Today!_**






**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 , LinkedIn and Twitter .


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. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm

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Posted: 2019-12-23 Expires: 2020-02-10

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Senior Regulatory Affairs Specialist

Kelly Services
Somerville, NJ 08876

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