When 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.
The Regulatory Affairs Specialist I will draft, assemble, and file original documentation and submission materials for new or existing products to regulatory authorities to assure that all submissions are accurate, of high quality
and well supported by literature and regulatory foundations, are presented in a manner to facilitate review, and are in conformance with appropriate statutes, regulations, and guidelines
- Track submissions, initiating internal communications and activities to adequately respond to agency inquiries and requests.
- Represent Regulatory Affairs on assigned project teams through all phases of product development; communicate regulatory requirements and the impact of regulations to the development team to ensure compliance for global product development, labeling, and/or promotional issues.
- Attends product development team meetings that include, but are not limited to marketing requirement reviews, system requirement reviews, design reviews, hazard analysis/risk assessment reviews, timeline development/reviews, and V & V reviews.
- Develops the regulatory strategy for project team(s).
- Applies advanced regulatory expertise to the evaluation and solution of submission problems.
- Actively reviews and edits documents associated with product development meetings.
- Independently review changes in products, product specifications, and manufacturing processes to assess regulatory implications of the change.
- Review and approve assigned product labeling, advertising and promotional materials, to ensure full compliance with all applicable FDA and other relevant regulations and industry guidelines.
- Responsible for vigilance activities, including filing and monitoring recalls/corrections/FSCA, incidents, and MDR’s.
- Review and interpret scientific literature and summarize effectively in writing.
- Remain current on developments in field(s) of expertise, regulatory requirements, and industry trends.
- Ensure training and compliance with global quality system regulations.
- Maintains on-going surveillance and analysis of all pertinent domestic and international in vitro diagnostic and medical device regulations to ensure submission requirements world-wide are current, up-to-date.
- Ensures that information of such regulations and requirements, especially those that are new or modified, are distributed to appropriate personnel.
- Identifies and routinely uses the most effective, cost efficient and best practices to execute processes; continually evaluates their effectiveness and appropriateness.
- Prepares documents necessary for new product market clearance, approval, and continuance during product life cycle management that includes, but not limited to, 510Ks, supplements, and technical files for CE marketing
- Regular contact and interaction with all levels of the organization
- Daily interaction will occur with technical product owners
- All Regulatory personnel are expected to maintain the confidentiality of sensitive laboratory information including testing data
- Maintain a cooperative and professional relationship with other laboratory staff and departments
- Bachelor’s degree in Biology, Chemistry, bio-engineering or related scientific area or two years’ experience in the device / diagnostic, biologic, and / or pharmaceutical industry, primarily in the area of regulatory affairs or working with molecular instrumented products
- 1-2 years of IVD Regulatory Affairs experience
- Well versed/knowledgeable 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 Distributors
- Regulatory review experience of promotional marketing materials, press releases, labeling, etc.
- Strong oral and written communication skills, as well as the ability to provide scientific presentations
- Ability to compile data and summarize results
- 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
- Background in diagnostics
- IEC 62304/Software Design knowledge
- Post-market experience in an ISO 13485
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.
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