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20 days old

Regulatory Affairs Specialist

Kelly Services
West Hills, CA 91307
Kelly Services has been providing outstanding employment opportunities to the most talented individuals in the marketplace. We are proud to offer a long-term temporary opportunity to work as a **Regulatory Affairs Specialist** at a prestigious Fortune 500 company working in **West Hills** .





**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 button to submit your resumes. If you have questions about the position, you may contact the recruiter for this position ( Brooke.Schoen@kellyservices.com ) however your resume must be received via the Submit Resume button included within.





**Job Title: Regulatory Affairs Specialist**





**Pay Rate: $45/hr**





A minimum of a Bachelors Degree in science or life science is required.





Minimum of 3 years experience in the device/diagnostic area of regulatory affairs .




Current knowledge of U.S. medical device and in vitro diagnostic regulatory requirements, Good Laboratory Practices (GLP), and Quality System Regulations (QSR); current knowledge of European Medical Device and IVD Directive requirements and European quality system standards.




Knowledge of Canadian and Japanese device regulations desired.





**Duties**




+ Track submissions, initiating internal communications and activities to adequately respond to agency inquiries and requests.

+ Represent Regulatory Affairs on assigned project teams through all phases of product development; communicate regulatory requirements and the impact of regulations to the development team to ensure compliance for global product development, labeling, and/or promotional issues.

+ Attends product development team meetings that include, but are not limited to marketing requirement reviews, system requirement reviews, design reviews, hazard analysis/risk assessment reviews, timeline development/reviews, and V & V reviews.

+ Develops the regulatory strategy for project team(s).

+ Applies advanced regulatory expertise to the evaluation and solution of submission problems.

+ Actively reviews and edits documents associated with product development meetings.

+ Independently review changes in products, product specifications, and manufacturing processes to assess regulatory implications of the change.

+ Review and approve assigned product labeling, advertising and promotional materials, to ensure full compliance with all applicable FDA and other relevant regulations and industry guidelines.

+ Review and interpret scientific literature and summarize effectively in writing.

+ Remain current on developments in field(s) of expertise, regulatory requirements, and industry trends.

+ Ensure training and compliance with global quality system regulations.

+ Maintains on-going surveillance and analysis of all pertinent domestic and international in vitro diagnostic and medical device regulations to ensure submission requirements world-wide are current, up-to-date.

+ Ensures that information of such regulations and requirements, especially those that are new or modified, are distributed to appropriate personnel.

+ Identifies and routinely uses the most effective, cost efficient and best practices to execute processes; continually evaluates their effectiveness and appropriateness. Prepares documents necessary for new product market clearance, approval, and continuance during product life cycle management that includes, but not limited to, 510Ks, supplements, and technical files for CE marketing

+ Draft, assemble, and file original documentation and submission materials for new or existing products to regulatory authorities to assure that all submissions are accurate, of high quality and well supported by literature and regulatory foundations, are presented in a manner to facilitate review, and are in conformance with appropriate statutes, regulations, and guidelines







**We invite you to bookmark our Web site and encourage you to review it regularly for new opportunities worldwide:** www.kellyservices.com at http://www.kellyservices.com/ **.**



**_Kelly Services is a U.S.-based Fortune 500 company. With our global network of branch locations, we are uniquely positioned to provide our customers with international staffing support and our employees with diverse assignments around the world._**



**Kelly Services is an Equal Opportunity Employer**








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



Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.




**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/non-traditional 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 and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.

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Posted: 2020-11-13 Expires: 2020-12-14

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Regulatory Affairs Specialist

Kelly Services
West Hills, CA 91307

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