How will you make an impact?
- Thermo Fisher is seeking an experienced Regulatory Affairs professional to join the exciting area of molecular diagnostic products. Main area of focus is leading covid-19 regulatory effort.
- This position will provide strategic and tactical support to In-Vitro Diagnostic core teams and can be located at either the Austin, TX, Carlsbad, CA, Pleasanton, CA, or South San Francisco, CA sites.
- The position 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: EUA, 510(k), or PMA.
- This Regulatory Affairs professional will support the COVID-19 business through utilization of our PCR or other relevant technologies.
- Title is dependent upon experience.
What will you do?
- Responsible for providing 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.
- 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.
- Serve as the regulatory core team lead and provide active and ongoing regulatory guidance to project teams
- Document regulatory strategies for product submissions.
- Facilitate and prepare U.S. regulatory Pre Submission and pre-EUA documents
- Facilitate FDA pre submission meetings
- Prepare U.S. regulatory submissions (EUA, 510(k), and/or PMA, PMA supplement) for COVID-19 and/or PCR assays
- Support EU representatives in their creation of CE/IVD Technical Files
- Support global regulatory registration representatives for product global registration activities
- 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
How will you get here?
A minimum B.Sc. degree in Biology, Chemistry, bio-engineering or related science.
- Must have a minimum of 4 years of Medical Device and/or IVD Regulatory Affairs experience.
- This experience must include either EUA, 510(k), PMA, or 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 co-development partners.
- Regulatory review of promotional marketing materials, press releases, labeling, etc.
- Demonstrate in-depth understanding of advanced technical/scientific principles related to IVD reagent chemistry, laboratory automation, and software components of IVD medical devices.
- Capacity to communicate regulations to technical functions within the company
Knowledge, Skills and Abilities
- 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
- Ability to provide solutions based on knowledge of regulation and industry experience
- Willingness to travel (~10-15%)
- Comfortable with ambiguity and change