Thermo Fisher is seeking a Regulatory Analyst to join the exciting area of in vitro diagnostics. This position will provide tactical support to In-Vitro Diagnostic core teams and will be located at its Santa Clara facility. The incumbent will work in the Global Regulatory Affairs department and will be responsible for the Santa Clara site regulatory activities providing regulatory assessment of the on market product changes and complaint assessment for MDR reporting in order to support in vitro diagnostic programs utilizing multiplex array genotyping technologies. In addition, incumbent will review advertising and promotional materials on IVD and RUO products ensure adherence to established processes, policies and procedures.
The Regulatory Analyst will be responsible for providing Regulatory Affairs support to Life Technologies, Affymetrix project teams and external partners. The delivery of regulatory guidance to project teams and external partners are key activities toward assisting the Company in achieving its business goals. Incumbent will serve as a member of the Global Regulatory department and will have direct line reporting to: Sr. Manager of Regulatory Affairs.
As one of the department’s regulatory experts, the incumbent is required to provide guidance to assure that all changes to existing products are reviewed per regulations and that the advertising and promotional material is alignment in internal policies and external regulations/guidance. In addition, this position serves as a subject matter expert on various regulations and coordinates regulatory issue resolution through the use of internal resources, regulatory agencies, and outside consultants as needed. Requires the ability to provide solutions based on their own knowledge and industry experience base. Detailed activities include:
- Provide active and ongoing regulatory guidance to project teams by participating in project team meetings
- Update/create CE/IVD Technical Files
- Perform regulatory assessment of new and changed products
- Perform complaint assessment to determine MDR reporting
- Review advertising and promotional materials against internal policies and external guidance/regulations.
- Prepare ex-US registrations and communicate with Regulatory Affairs counterparts in other regions (outside the US) to ensure registration documents are provided in a timely fashion to support existing IVD products.
- Keep abreast of new or revised regulations, guidelines, points to consider, compliance guides, inspection reports, journals, meetings, etc.
- Assist Regulatory department in the update, enhancement, and creation of internal policies and procedures.
- Participate in business meetings with existing and potential new external partners.
REQUIREMENTS / EDUCATION:
- Must have a minimum of 3 years within the IVD industry; Regulatory Affairs or Quality Assurance experience preferred. Must be well versed in the aspects of regulatory submissions (ex-US a plus), design control, and cGMP/Quality Systems.
- Experience on project core teams providing active and successful regulatory guidance.
- Experience in the balance and application of regulatory requirements.
- Review of promotional marketing materials, advertising, labeling, etc.
- A minimum B.Sc. degree in Biology, Chemistry, bio-engineering or related science.
- Experience working across multiple manufacturing sites is recommended.
This position has not been approved for Relocation Assistance.