Thermo Fisher Scientific Regulatory Affairs Specialist III in Pleasanton, California
When you're part of the team at Thermo Fisher Scientific, you'll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you'll be supported in achieving your career goals.
Location/Division Specific Information
How will you make an impact?
Thermo Fisher is seeking a Regulatory Affairs specialist 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 activities.
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 recall strategies.
These interactions will enable global reporting requirements within the appropriate time restrictions, for regulatory authorities reporting.
In addition, you may participate in process improvement projects, and assist with inspections and audits.
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 customer notifications
Follow up with regional sites for updates on recall status.
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 authorities.
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 individuals desired
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
Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.