Sr Regulatory Affairs Specialist/ Manager

Job Title: Sr Regulatory Affairs Specialist/ ManagerRequisition ID- 130377BRWhen 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.Location/Division Specific InformationAustin, TX, South San Francisco, Carlsbad, or Pleasanton, CA, LSG OperationsHow 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?EducationA minimum B.Sc. degree in Biology, Chemistry, bio-engineering or related science.Experience:

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

This position does not have relocation assistanceAt Thermo Fisher Scientific, each one of our 75,000 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! http://jobs.thermofisher.comThermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.