Sr Regulatory Affairs Specialist /IVD

08 Jun, 2021


Sr Regulatory Affairs Specialist /IVD

Thermo Fisher Scientific
San Diego, CA

When you’re a 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. How will you make an impact?

• 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.

• 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 US regulatory pre-submission documents for PCR assays/instrumentation

• Facilitate FDA pre submission meetings

• Prepare US regulatory submissions (510 (k)) for 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 there?

Education • A minimum B.Sc. degree in Biology, Chemistry, bio-engineering or related science.

Experience • Must have a minimum of 5 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 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, abilities

• High energy level; Must have a minimum of 5 years of IVD Regulatory Affairs experience. • 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

Learn more here

Job posted: 2021-06-08