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20 days old

Regulatory AffairsSpecialist

Kelly Services
Sunnyvale, CA 94086
Regulatory Affairs Specialist III- Sunnyvale, CA (REMOTE)


This is a full time 1 year long contract position with strong potential for extension or conversion. This position is based out of Sunnyvale, CA but is fully REMOTE


**OVERVIEW** :


Regulatory Affairs Specialist will prepare the regulatory submissions and interact with Distributors, Regulatory Agencies, and Health Authorities to obtain and maintain product approvals. Prepare regulatory submissions for countries with focus on LATAM, Canada, APAC, and EMEA regions.


**RESPONSIBILITIES** :


+ Communicates with in-country Regulatory Affairs personnel to facilitate global clearances/approvals.

+ Communicates with internal and external stakeholders in support of IVDR-related change assessments.

+ Coordination with department personnel from regulatory, quality, and manufacturing sites, sales and marketing.

+ Organizes and maintains files such as IVDR Survey, IVDR Transition tracker and other RA related materials.

+ Regulatory review and approval of design, manufacturing, labeling, packaging-related changes in compliance with applicable regulations and providing Regulatory Change Assessments through RCA .

+ Prepare formal written reports, PowerPoint presentations, and documents for distribution within work unit and regions.


**REQUIREMENTS:**


+ Bachelor's degree in Life Science or related field with 2+ years of Quality or Regulatory experience -OR-

+ Master's degree in in a Life Science or related field with 1-2 years of Quality or Regulatory work experience

+ IVD product experience is highly preferred


**KNOWLEDGE AND SKILLS:**


+ Demonstrate in-depth understanding of advanced technical/scientific principles that relate to multiple, diverse, and or complex product lines or manufacturing processes

+ Ability to interpret subjective and complex aspects of specific regulations and has thorough understanding of multiple sets of associated regulations

+ Prior knowledge of different databases like Trackwise, Agile documentation control systems is preferred

+ Experience in regulatory/Quality or related departments within an IVD or medical device industry

+ Experience in regulatory change assessments is highly 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: 2022-04-29 Expires: 2022-06-02

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Regulatory AffairsSpecialist

Kelly Services
Sunnyvale, CA 94086

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