Sr. Regulatory Specialist
Company: Thermo Fisher Scientific
Posted on: July 14, 2021
Regulatory Affairs Specialist
Carlsbad, CA or Pleasanton, CA
Thermo Fisher is seeking a Regulatory Affairs
to join the post market Regulatory
Affairs team in supporting the
area of In Vitro Diagnostic
and Clinical Research products.
The position will be located at either the Carlsbad, CA or
Pleasanton, CA facility and will report administratively to the
Manager of Regulatory Affairs and work directly/functional with the
LSG Global RA Post Market Manager supporting post market regulatory
This position will interact with members of multiple site
Regulatory Affairs groups, Quality Assurance, Research &
Development, Product Management and Customer Facing teams as you
participate in complaint assessments, adverse event reporting, and
These interactions will enable global reporting requirements within
the appropriate time restrictions, for regulatory authorities
In addition, you may participate in process improvement projects,
and assist with inspections and
What will you do?
- Serve as a member of the Global Regulatory Affairs department
and will have direct reporting to the RA Manager, supporting the
Global RA post market manager.
- Function as a direct link between the Global and Local RA team
members to ensure local and regional regulatory reporting plans are
understood between the regions.
- Work with cross-functional teams in drafting and review of
- Follow up with regional sites for updates on recall
- Review regulated product complaints with site RA partners on
regular intervals to determine if recall, field action, or MDR/AE
reporting is required
- Draft and review global regulatory field action and MDR/AE
reports to ensure on-time submissions to the appropriate regulatory
- Participate in the creation of Health Hazard Evaluations for
issues potentially impacting patient/user health or safety.
- For adverse event and corrective action/recalls; monitor global
teams continued compliance with ISO 13485 and global regulatory
requirements from FDA, Health Canada, Therapeutic Goods
Administration, Medicines and Healthcare products Regulatory
Agency, and other applicable Health Authorities.
- Participate in process improvement projects.
- Support process owners and global product manufacturing sites
to address internal/external audit and inspection findings for
adverse event and recall/ product corrective actions.
- Interface with Quality Assurance and Customer Facing Teams for
product investigations and trend reporting.
- Maintain current knowledge of FDA and international regulation,
guidance and standards applicable to company products.
- BS/BA in scientific or engineering discipline
- 1-2 years Regulatory or Quality Assurance experience in the
IVD/Medical device industry
- Detail-oriented, critical thinking and process-oriented
- Complaint assessment experience in Quality Assurance or
Regulatory Affairs a plus
- Post market compliance experience in Quality Assurance or
Regulatory Affairs a plus, specifically 21 CFR 803 Medical
Device Reporting and 21 CFR 806 Medical Devices: Reports of
Corrections and Removals
Keywords: Thermo Fisher Scientific, Pleasanton , Sr. Regulatory Specialist, Other , Pleasanton, California
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