Regulatory Affairs Specialist

Job description

As part of Thermo Fisher Scientific, you'll do challenging work, and join a team that values performance, quality and innovation. As part of a successful, growing global organization you will be encouraged to perform at your best. With revenues of more than $35 billion and the largest investment in R&D in the industry, we give our people the resources and chances to create significant contributions to the world.

As part of the team at Thermo Fisher Scientific, you'll do important work developing rapid diagnostic solutions. Your work will have real-world impact, and you'll be supported in achieving your career goals.

Location/Division Specific Information

Thermo Fisher Scientific is seeking a Regulatory Specialist to join the rapidly growing area of IVD products within the Rapid Diagnostic Solutions (RDS) Group business unit. The main area of focus is RT-PCR In Vitro Diagnostic devices. This position will provide tactical support to In-Vitro Diagnostic core teams and is located at the San Diego, California facility.

How will you make an impact?

Provide Regulatory Affairs support to Thermo Fisher Scientific project teams and external partners. Main activities surround supporting regulatory submissions, guiding joint project teams through the "regulatory terrain", determining submission requirements, facilitating and authoring pre-submission documents and supporting 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.

What will you do?

As one of the Regulatory department's key contributors, the incumbent is required to provide support to assure that all regulatory submissions are planned, communicated and achieve regulatory and business requirements.

• In addition, this position serves as a project team advisor on various regulations and coordinates regulatory issue resolution using internal resources, regulatory agencies, and outside consultants as needed.
• Provide solutions based on their own knowledge and industry experience base. Detailed activities include:
• Provide active and ongoing regulatory guidance to project teams
• Document regulatory strategies for product submissions.
• Facilitate and prepare U.S. regulatory pre-submission documents
• Support FDA pre-submission meetings
• Support U.S. regulatory submissions (PMA and 510(k))
• Support EU representatives in their creation of CE/IVD Technical Files
• Perform regulatory assessment of new and changed products.
• Stay on top of new or revised regulations, guidelines, Standards, compliance guides, inspection reports, journals, meetings, etc.
• Conduct trainings and/or communicate appropriate materials, as needed, in order to improve team's knowledge of working in a regulated environment.
• Assist Regulatory department in the update, improvement, and creation of internal policies and procedures.
• Regulatory review of promotional marketing materials, press releases, labeling, etc.

How will you get here?

A minimum B.Sc. degree in Biology, Chemistry, bio-engineering or related science. Masters in Regulatory Affairs and/or RAC preferred.

• Must have a minimum of 3+ years of IVD Regulatory Affairs experience.
• Experience with 510(k) or PMA Submissions preferred.
• Must have working knowledge of CE mark process and IVDD to IVDR transition 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 interacting with Regulatory Authorities via pre submission and teleconferences.

Knowledge, Skills, Abilities

• Comfortable with ambiguity and change
• High energy level; positive outlook; works well under stress.
• Demonstrate working understanding of advanced technical/scientific principles related to IVD reagent chemistry, laboratory automation, and software components of IVD medical devices.
• Strong communicator
• Hands-on, proactive and able to implement effectively within a team
• Continuous improvement minded; familiar with balancing Quality and efficiency.
• Able to work autonomously in a matrix-managed organization
• Ability to provide solutions based on knowledge of regulation and industry experience

At Thermo Fisher Scientific, each one of our 90,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission-enabling our customers to make the world healthier, cleaner and safer.

Apply today!