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Regulatory Affairs Manager

Kelly Services

Santa Ana, CA
Job Code:
  • Government
  • Regulatory Affairs
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Job Details

Job Title Regulatory Affairs Manager

Jobid US33MXGR_BH1418683

Location: Santa Ana, CA, 92702, USA

Description Kelly Services is seeking a seasoned Regulatory Affairs Manager for an assignment budgeted through the end of 2019. The RA Manager will be providing global regulatory support for Class II OTC products. Candidates should have experience with 510k, US FDA submissions and in managing the overall execution of the submission process. This position requires work to be done onsite and can be based in either Santa Ana California or Jacksonville Florida.

Job duties include:

• Provides tactical and strategic regulatory leadership to the organization and oversees regulatory aspects of new product development and launches including the preparation and submission of required global regulatory submissions.

• Interprets regulatory requirements and oversees aspects of submission of licenses and authorizations for the maintenance of existing products, international registrations and dossiers including assessment of the impact product changes have on the status of regulatory licenses.

• Independently makes decisions regarding work processes or operational plans and schedules Represents regulatory affairs in cross-functional project teams and plans schedules for regulatory deliverables on a project and monitors project through completion.

• Prepares the responses to regulatory agency inquiries and other correspondence (either directly or indirectly through supervision of others)

• Establishment and Execution of Global Product Registration Plans for New Market

• Expansion and New Product Projects. Work should be done independently with limited oversight.


• BA/BS degree

• Approximately 5-8 years demonstrated regulatory affairs experience

• Experience in the medical device industry including 510k; Class II and/or OTC experience a plus

• MS Office proficiency; MS Project 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

**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 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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