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12 days old

Reg. Affairs Specialist II (West Hills, CA)

Kelly Services
West Hills, CA 91307
**Regulatory Affairs II (Scientific) West Hills, CA Roscoe Blvd**


**Pay Rate: $55.00/hour**


**Shift: 8am-5pm PST (On-site only)**


**Full-Time Contract (12 months, however there is possibility for Temp to Perm)**


**Job Description:**


Regulatory experience, submission experience What key words should be on the resume, FDA, 510k, regulatory, compliance, registrations What industries mirror this experience?


Device, Pharma experience required.


2 5 years Required


How would you describe the ideal person for this role: can multi task, knows the regulatory process, resourceful, or can work independently


Work Environment: dynamic, nimble, project and results orientated


What types of interviews will be required: phone, MS Teams, onsite


**Key Responsibilities:**


Develop and write clear processes for regulatory approvals Prepare submissions of license variations and renewals.


Monitor and set timelines for license variations and renewal approvals.


Work with R D teams to plan and develop strategy for design control and regulatory market access. Advise scientists and manufacturing teams on regulatory requirements.


Liaise with and participate in the interactions and negotiations with the FDA, Authorized Representatives, Competent Authorities, Notified Bodies, and other regulatory agencies to achieve regulatory approval.


Develop strategies to obtain appropriate regulatory clearances and assess the type and amount of product performance data required to ensure product approval.


Work on extremely complex problems where analysis of situations or data requires an evaluation of intangible, variable factors. Provide leadership for the regulatory function and coordinate activities directed toward obtaining marketing clearance for all diagnostic products.


**Minimum Requirements/Qualifications:**


Bachelor's degree required, with advanced degree preferred Minimum of 2-5 years of Regulatory Affairs Diagnostics industry experience is preferred.


**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**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)

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Posted: 2022-05-09 Expires: 2022-06-09

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Reg. Affairs Specialist II (West Hills, CA)

Kelly Services
West Hills, CA 91307

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