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Regulatory Affairs Specialist w/Medical Device Experience

Kelly Services


Location:
Plymouth, MN
Date:
04/23/2018
2018-04-232018-05-22
Job Code:
US33MXGR_BH1420990
Categories:
  • Business Development/Operations
  • Government
  • Regulatory Affairs
  • Project Management
Kelly Services
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Job Details

Job Title Regulatory Affairs Specialist w/Medical Device Experience

Jobid US33MXGR_BH1420990

Location: Plymouth, MN, 55446, USA

Description Kelly Services is seeking a **Regulatory Affairs Specialist with Class II medical device experience for a one year contract assignment in Plymouth, MN** . The Regulatory Affairs Specialist provides regulatory support for new and existing products and acts as the primary onsite contact for all team members. The Regulatory Affairs Specialist participates in team meetings and provides general regulatory guidance and support in the resolution of real-time issues.

Tasks/Duties/Responsibilities

• Ensures compliance with regulatory agency regulations and interpretations.

• Prepares responses to regulatory agencies’ questions and other correspondence.

• Gathers and assembles information necessary for submissions in accordance with regulations and relevant guidelines.

• Involved with the preparation of necessary outlines, summaries, status reports, memos, graphs, charts, tables, and slides.

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

• 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 regulatory labeling requirements specifications for new and modified products, and reviews product labeling to ensure compliance.

• Provides regulatory guidance to product development teams and responds to product information requests.

• Provides regulatory affairs support during internal and external audits.

• Represents regulatory affairs on cross-functional project teams.

• Reviews engineering documents (protocols and test reports), reads and interprets regulatory documents, and prepares document change orders as needed.

Qualifications:

• BA/BS in Life Science, Engineering, or other scientific discipline

• 3-5 years regulatory affairs experience in the medical device industry (Class II)

• Team player with excellent interpersonal and collaboration skills.

• Product development background.

• Ability to leverage scientific and technical understanding of regulated products within scope of responsibility to provide regulatory input to product life-cycle management and evaluate regulatory impact on products.

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

• The ability to support complex projects through timely and effective decision making based on available information.

• Working knowledge of global medical device regulations. Project management experience a plus

If you meet the qualifications above and are interested in pursuing this opportunity, please submit your resume for immediate consideration!

Perks of being a Kelly employee:

• Weekly electronic pay

• Access to more than 3,000 online training courses though Kelly Learning center

• Group rate insurance options available immediate upon hire*

• Service bonus plan and holiday pay*

• Online application system

• Never an applicant fee

*perks to be received upon meeting eligibility requirements

Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must use the Submit Resume or Apply Now button to submit your resume. If you have questions, the recruiter for this position can be reached via email at gail.robilliard@kellyservices.com.

**Why Kelly** **®** **?**


With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevantprojects. Our connections can lead you to innovative scientific pursuits you’ll be proud to helpadvance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 9,000scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the worlda better place. Let Kelly fuel your career—connect with us today.

**AboutKelly Services** **®**

As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit kellyservices.com and connectwith 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 iscommitted to employing a diverse workforce. Equal Employment Opportunityis The Law.



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