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Regulatory Affairs Manager
Thermo Fisher Scientific is seeking an experienced Regulatory Affairs Manager to join the exciting area of Molecular Diagnostic products. Main area of focus is Oncology including Companion Diagnostics. This position will provide strategic and tactical support to In-Vitro Diagnostic core teams and can be located at its South San Francisco, Pleasanton or Carlsbad facilities. The incumbent will work in the Global Regulatory Affairs department and will establish and execute the regulatory strategies, lead FDA pre-submission package development and subsequent meetings and author final product submissions: PMA, PMA supplements, or 510(k). These activities are key to supporting our Oncology business through the utilization of our Next Generation Sequencing and PCR technologies. In addition, incumbent will ensure adherence to established processes, policies and procedures.
Position Objective Overview:
Provides Regulatory Affairs guidance/support to Thermo Fisher Scientific project teams and external partners. Main activities surround developing product regulatory strategies, guiding joint project teams through the “regulatory terrain”, determining submission requirements, facilitating and authoring pre-submission documents and subsequent meetings, as well as authoring final submission packages. The delivery of regulatory guidance to the business, 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: either a Sr. RA Manager or the Director of Regulatory Affairs/ Clinical.
- Provide guidance to assure that all regulatory submissions are planned, communicated and executed per regulatory and business requirements. 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:
- Document regulatory strategies for product submissions.
- Serve as the regulatory core team lead and provide active and ongoing regulatory guidance to project teams
- Facilitate and prepare U.S. regulatory Pre Submission documents for Next Generation Sequencing and/or PCR assays
- Facilitate FDA pre submission meetings
- Prepare U.S. regulatory submissions (PMA, PMA supplement, and 510(k)) for Next Generation Sequencing and/or PCR assays
- Support global regulatory registration representatives for product global registration activities
- Support EU representatives in their creation of CE/IVD Technical Files
- 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.
- Conduct trainings and/or communicate appropriate materials, as needed, in order to enhance team’s knowledge of working in a regulated environment.
- Assist Regulatory department in the update, enhancement, and creation of internal policies and procedures.
- Participate in business meetings with potential new external partners
- 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 either 510(k), PMA, PMA supplement submissions. 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, press releases, 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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