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26 days old

Regulatory AffairsSpecialist - REMOTE

Kelly Services
Sunnyvale, CA 94086 Work Remotely
PLEASE NOTE: Must be authorized to work lawfully in the United States for any employer without sponsorship.


Kelly Science & Clinical is seeking a Regulatory Affairs Specialist to join their team remotely for an American molecular diagnostics company whose systems automate traditional nucleic acid tests that can be used to identify and analyze pathogens and genetic disorders. For immediate consideration, please email your resume directly to Regan.Brown@KellyServices.com as well as apply online.


**Title: Regulatory Affairs Specialist**


**Contract: Duration = ~12 Months, Potential to Convert = No Guarantee (full-time/non-exempt/W2)**


**Pay Rate: TBD (commensurate with experience)**


**Schedule/Shift: Flexible/Standard**


**Travel: 10% Possible to Sunnyvale, CA**


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, and EEMEA 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, labelling, 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:


+ Bachelors degree in a related discipline or relevant work experience.

+ Related, regulatory affairs work experience is required.

+ Medical device experience is preferred but not required.

+ IVD/IVDR experience is preferred but not required.

+ Ability to multitask, support multiple projects, prioritize, conduct team meetings, and meet project deadlines.

+ Excellent written and verbal communication skills with the ability to listen, articulate, and advocate.

+ Proactive, high performance, and result oriented.


**Why Kelly:**


As a Kelly Services employee, you will have access to numerous perks, including:


+ Exposure to a variety of career opportunities as a result of our expansive network of client companies.

+ Career guides, information and tools to help you successfully position yourself throughout every stage of your career.

+ Access to more than 3,000 online training courses through our Kelly Learning Center, including accredited courses to obtain IT certifications, as well as PDU-approved courses.

+ Weekly pay.

+ Group-rate insurance options available immediately upon hire.*


**Apply today!**


**Refer a friend!**


*Available for purchase and administered by a designated third-party vendor. (P1/PR50)


**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: 2022-05-02 Expires: 2022-06-02

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Regulatory AffairsSpecialist - REMOTE

Kelly Services
Sunnyvale, CA 94086

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