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10 days old

Regulatory Affairs Specialist

Kelly Services
Los Angeles, CA 90006
**Regulatory Affairs Specialist in Los Angeles, CA**


We're seeking an experienced quality professional to join a leading medical and scientific company. The successful candidate will handle regulatory submissions, CAPAs, customer complaints, conduct regulatory reviews, and participate in audits. Offering highly competitive salary and benefits.


**Responsibilities**


+ Assure compliance with the company Quality Operations and Regulatory Affairs program

+ Maintain and implement the Quality Management System and Regulatory Affairs Program

+ Perform Document Control Administration

+ Handle Customer Complaints and Returns (Supports Customer Contact Program)

+ Maintain CAPA system and work cross-functionally to resolve matters

+ Perform Internal Audits and External Audits of Suppliers


**Qualifications**


+ Bachelors degree in a scientific field

+ Minimum 5 years of quality assurance, regulatory affairs

+ Experience in a medical device environment.

+ Experience in pharmaceutical industry and requirements strongly desired.

+ Experience with QA systems and Product registrations: FDA, **ISO 13485,** MDR/MDD, MDSAP

+ Knowledge of FDA medical devices and pharmaceutical (drugs) registrations (510k, DMF, NDA, ANDA).

+ Knowledge of ISO 14971 and implementation of risk management in medical device and

+ pharmaceutical industry.

+ Knowledge of Product Validation desired.

+ Self-starter and strong communicator.

+ Able to work independently or in a team environment.

+ Project management experience and able to manage to timelines.

+ Detail oriented, organized and excellent written & verbal skills.

+ Excellent planning, organization, and flexibility to adjust to changing environment.


_Fast track the process and apply today! Qualified talent will be contacted within 24 hrs._


**If youre unable to apply through the website, please email your resume in Word format and position title to** **JEND557@kellyscientific.com** **.**


_Kelly Science & Clinical is the premier destination for Scientific Professionals seeking Direct-Hire, Temp-to-Hire, and Contract positions across the country. Scientific Recruiters are ready to select and represent the best candidates to join their award-winning scientific clients._


\#TJP2021_SPEC


**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/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of benefits ?). 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. (https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm)
Posted: 2021-04-28 Expires: 2021-05-29

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Regulatory Affairs Specialist

Kelly Services
Los Angeles, CA 90006

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