Regulatory Affairs Specialist /Post Market
Carlsbad, CA or Pleasanton, CA
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.