Regulatory Affairs Senior Specialist (South San Francisco)
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.
Regulatory Affairs Senior Specialist
Thermo Fisher Scientific is seeking an experienced Senior Regulatory Affairs Specialist to join the exciting area of Molecular Diagnostic products. This position will provide strategic and tactical support to the Genetic Sciences In-Vitro Diagnostic business and core teams by providing the business with the scope and requirements for CE marking select existing and new non IVD labeled products. The incumbent will work in the Global Regulatory Affairs department and will scope, document and execute regulatory strategies for the qPCR and CE sequencing businesses as well as prepare technical files/ product dossier development.
Along with CE IVD implementation; this position may also move toward exploring the requirements for the US and other Ex US regions such as China and Japan. This area of focus will require US IVD core team and submission experience as well as the ability to reach out/ interface with our Ex US regulatory teams in order to determine the scope and requirements for these other non EU/non US regions.
Position Objective Overview:
Provides Regulatory Affairs guidance/support to Thermo Fisher Scientific business and project teams. Main activities surround providing guidance to the GSD business related to CE IVD project scoping and planning, developing product regulatory strategies, guiding joint project teams through the “regulatory terrain”, determining tech file and submission requirements, facilitating and authoring registration and submission documents. The delivery of regulatory guidance to the business and project teams are key activities toward assisting the Company in achieving its business goals. Incumbent will serve as a member of the Global Regulatory department.
- Provide CE IVD regulatory guidance to the business and project teams
- Document regulatory strategies for product CE marking and other submissions.
- Prepare CE IVD tech files and other submissions as needed ie US
- Communicate with Ex US RA representatives (as needed) to ensure RA strategy is in alignment with current regulations
- Communicate to non EU / non US teams any submission requests
- Provide feedback to GSD team concerning non EU / non US submission requests
- 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:
- Serve as the regulatory core team lead and provide active and ongoing regulatory guidance to project teams
- Perform regulatory assessment of new and changed products.
- Keep abreast of new or revised regulations, guidelines, points to consider, compliance guides, inspection reports, journals, meetings, etc.
- A minimum B.Sc. degree in Biology, Chemistry, bio-engineering or related science.
- Must have a minimum of 4 years of IVD Regulatory Affairs experience.
- This experience must include CE IVD requirements and Tech File creation. 510(k) experience is a plus.
- Must be well versed in the aspects of regulatory strategy creation, design control, cGMP/Quality Systems, and import/export requirements.
- Experience as the RA representative on project core teams providing active and successful regulatory guidance and RA strategies.
- Experience in the balance and application of regulatory requirements
- Direct and positive experience in communicating with Regulatory Authorities and Distributors.
- Regulatory review of promotional marketing materials, labeling, etc.
- High energy level; positive attitude; works well under stress, Strong communicator and leader
- Hands-on, action-oriented, and able to implement effectively through his/her team
- Continuous improvement minded; familiar with balancing the need for Quality and the need for efficiency
- Able to work autonomously in a matrix-managed organization
- Willingness to travel (~10-15%)
- Comfortable with ambiguity and change
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