1+ months

Sr Regulatory Affairs Specialist

Kelly Services
Irvine, CA 92604
Kelly Services Outsourcing & Consulting Group is seeking a Sr. Regulatory Affairs Specialist in Irvine CA. This is a long term position with benefits! The Sr. Regulatory Affairs Specialist will develop and implement regulatory strategies and processes to assure timely global commercialization of products in compliance with applicable medical device regulations and standards.


Ensure compliance with global regulations and regulating agencies.

Interpret the intent of regulations and policies and provide such information to project teams and management.

Develop Technical Documentation Files following the requirements of the EU Medical Device Regulation for class II and III medical devices to obtain or maintain CE Marking.

Conduct submission negotiations with the European Notified Bodies as needed, including pre-submission identification of requirements and strategy and post submission negotiations to ensure timely approval.

Maintain proficiency on regulatory requirements and develop and maintain rapport with Notified Body reviewers, project team members.

Provide continuing regulatory education and dissemination of regulatory information to the product development, marketing, and clinical groups.

Manage the generation of documentation to be submitted to worldwide governmental regulatory agencies in order to secure approvals to market products manufactured

Follow all Company guidelines related to Health, Safety and Environmental practices.

Comply with all Federal, State, local and Company regulations, policies, and procedures.

Performs other duties assigned as needed.


Bachelors Degree in engineering, physical or biological science or related field of study; MS degree preferred.

3+ years experience in regulatory affairs in the medical device industry.

Regulatory experience with devices containing software preferred.

Proven expertise in all aspects of Regulatory Affairs, Submission Preparation, EU Medical Device Regulation, FDA Device Law/Regulations, World Wide Regulatory Requirements/Procedures, Project Management, and Negotiations.

International clinical and regulatory experience desired.

Prefer experience in the cardiovascular/cardiology field.

Must be able to communicate effectively in a professional environment.

Must be able to influence without authority


Location: Irvine, CA, with possibility to occasionally work remotely per arrangements with manager.

Travel: 10% travel, both domestic and international may be requested.

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

This position comes with enhanced benefits which include:

50/50 shared healthcare cost (Kelly pays 50% of the monthly premium, employee pays 50%)*

Paid sick days and vacation days*

Perks of being a Kelly employee:

Weekly electronic pay

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

Online application system

Never an applicant fee

*benefits 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.

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

As a worker today, its up to you to take charge of your career and look for opportunities to learn, grow, and achieve your potential. Helping you find whats next is what were all about. We know whats going on in the evolving world of workjust ask the nearly 500,000 people we employ each year. Connecting with us means getting the support, guidance, and opportunities needed to take your career where you may have never imagined.

**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. 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.



Posted: 2019-12-30 Expires: 2020-03-21

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Sr Regulatory Affairs Specialist

Kelly Services
Irvine, CA 92604

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