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27 days old

Regulatory Quality Assurance Specialist

Kelly Services
Fremont, CA 94536
Kelly Services has been providing outstanding employment opportunities to the most talented individuals in the marketplace. We are proud to offer a six month temp-to-hire opportunity to work as a **Regulatory Quality Assurance Specialist** at a prestigious Fortune 500 company working in **Fremont, CA.**


**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 Quality Assurance Specialist**


**Pay: $76 per hour depending on experience**


**Position Summary** :

Co-ordinates and prepares document packages for regulatory submissions from all areas of the organization. Collects all materials required in submissions, license renewal, and annual registrations. Keeps abreast of regulatory procedures and changes. May interact with regulatory agencies. Works on problems of complex scope where data analysis requires evaluation of specific factors. Utilizes independent judgment within broad parameters to determine an appropriate solution. May determine methods and procedures on new projects and may provide guidance to other lower-level staff. This is an individual contributor role that requires the use of judgement in applying professional expertise and is expected to work independently with minimal supervision.


Roles typically require a university degree or an extensive amount of practical knowledge gained through experience. Job requires an understanding and application of procedures and concepts of own discipline. The job requires the ability to make judgements based on practice and previous experience. This job typically requires a degree or equivalent and no experience.


**Essential duties & responsibilities** :


Manage and transact data between several company systems keeping the database as source of truth for various internal clients.


Perform actions on RA Configuration Management System to release or block shipment of products to one or more of the following geographic regions: United States, Europe, Canada, and International.


Execute product holds and releases actions in a timely manner to assure business continuity and avoid back orders.


Assist in creating and executing relevant RA metrics to support strategic planning.


Author SOP/Work Instructions related to scope of work.


Uses existing systems and procedures and recommends solutions and/or improvements.


Provide professional representation of RA in cross functional projects and multifunction boards.


Provide support on Change Notifications, Device Notifications, UDI submission to FDA and NC/CAPAs for Domestic and International RA.


Experience working on systems & process change implementation projects.


Hold self-accountable to deliver on tasks & meet business deadlines.


Organize and maintain RA files such as Responsibilities Matrix, Certificates from Notified Bodies (FSC and CFG) and other RA related material.


Provide document packages for regulatory submissions in one or more of the following geographic regions: United States, Europe, Canada, and International.


Assist on submissions publications for regulatory submissions to Regulatory Agencies in the US, Canada and Europe.


Notarize documents that will be used in regulatory submissions in one or more of the following geographic regions: United States, Europe, Canada, and International.


Ensures that existing approvals and documentation are maintained.


Communicates with in-country RA personnel to facilitate global clearances/approvals.


Performs responsibilities required by the Quality System and other duties as assigned or requested.


Fully support the Quality Policy by building quality into all aspects of the incumbent's work and by maintaining compliance to all quality requirements (including but not limited to being current on all training requirements for the incumbent's position and documenting that training).


**We invite you to bookmark our Web site and encourage you to review it regularly for new opportunities worldwide:** 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/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: 2021-05-24 Expires: 2021-06-24

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Regulatory Quality Assurance Specialist

Kelly Services
Fremont, CA 94536

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