Manager, Regulatory Affairs
Company Overview
Thermo 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.
Title: Manager, Regulatory Affairs
Location: Middletown, VA preferred. Potential for remote/hybrid with travel.
Shift: 1st Shift, must support East Coast business hours
Position Summary
As 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 information
Provide 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:
Minimum Education and Experience
- Undergraduate degree in scientific field required; advanced degree preferred.
- Minimum of 5 years of IVD or Medical Device Regulatory Affairs experience
- 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.
Knowledge, Skills, Abilities
- Hands-on experience with classification of devices; listing, registration, and approval of devices required; adverse event reporting, and recalls desired.
- 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.
- Proficiency with the English language
Travel requirement:
- If remote, travel to the site will be required.
Our Mission is to enable our customers to make the world healthier, cleaner and safer. As one global team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need.
Apply today! http://jobs.thermofisher.com
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.
Accessibility/Disability Access
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. Please contact us to request accommodation.