Manager, Regulatory Affairs

Job DescriptionCompany overviewThermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $35 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving sophisticated analytical challenges, improving patient diagnostics and therapies or growing efficiency in their laboratories, we are here to support them.Position summaryAs Regulatory Affairs Manager you will be responsible for developing a high-functioning Regulatory Affairs team at the Thermo Fisher Scientific, Clinical Diagnostics Divisional level. The Clinical Diagnostics Division (CDD) is an organization made up of business units which develop, manufacture and market instruments and consumables that serve a broad, diverse mix of diagnostic segments. This is a vital role supporting the Middletown site manufacturing in vitro diagnostic reagents.Key Responsibilities:Evaluate the regulatory environment and support the products for the site. Advise on the optimal regulatory strategies, submissions product changes, and approval pathways.Partner with R&D, marketing, operations, and legal leadership with the Middletown site to interpret and apply regulatory requirements and intelligence. Participates in inspections/audits by the notified body or other international regulatory bodies by producing requested documents or answering any inquiries for informationProvide regulatory strategy leadership and expertise to enable an optimized go-to-market approach for both Middletown business functions and IVD OEM partners.Lead interactions with global regulatory authorities and partners to gain alignment on regulatory strategies and resolve concerns to expedite approval of pending applications. Remain well-versed in evolving global regulatory policies and advise Middletown site internally on anticipated changes, net business effect and develop appropriate strategies/processes to appropriately address.Supervise team to author and submit documentation for regulatory agencies, review labeling, and other requirements documents. Prepares documents vital for new product market clearance, approval, and continuance during product life cycle management that includes (but is not limited to) 510(k)s, or technical files for CE marking.Qualifications:

Undergraduate degree in scientific field required; advanced degree preferred.

Minimum of 6 years of IVD or Medical Device Regulatory Affairs experience or 4 years with advanced degree

Hands-on experience with classification of devices; listing, registration, and approval of devices required; adverse event reporting, and recalls desired.

Experience interpreting and working under the regulations governing the approval of new products and the expectations and processes employed by the FDA and EU agencies, CE mark, 510k, PMA, EUA, technical files and design dossier. Additional experience with similar ex-US regulators (e.g. Japan PMDA, China NMPA, Brazil ANVISA, Health Canada etc.) ideal.

Possess IVD technical expertise and regulatory knowledge to lead products through the approval and commercialization phases.

Experienced in direct, professional, regulatory interactions with customers and OEM business partners.

Technically savvy using IT databases and familiarity with commercial digital tools desired.

Ability to get results in a matrixed organization, especially having representatives from different cultures come together, encouraging diversity.

Demonstrated ability to manage personnel through project experience or projects.

Travel requirement:

If remote, travel to the site will be required.

Thermo 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.We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.Thermo 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.