Thermo Fisher Scientific Senior Regulatory Affairs Manager in San Jose, California
Senior Regulatory Affairs Manager
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.
How Will You Make an Impact?
The Senior Regulatory Affairs Manager is responsible for the overall management of regulatory affairs in order to remain in compliance with FDA, and all other U.S. and international regulatory requirements for Medical Devices and/or In-Vitro Diagnostics .
What will you do?
Coordinates submissions to FDA and other Regulatory Agencies, including International Authorities.
Ensure rapid and timely approval of new products and continued Regulatory support of marketed products.
Partners with cross functional teams by providing regulatory guidance and support to product development teams for strategic planning, design and development, and post-market surveillance and compliance activities.
Reviews and analyzes technical protocols, data, and reports generated by Product Development, Operations, Clinical Research, Quality Assurance or other related departments.
Provides regulatory advice to project teams.
Creates detailed Regulatory Plans. Includes in-depth team involvement, including Core Team membership for complex projects.
Evaluates proposed product modifications for Regulatory impact on a world-wide basis.
Completes Regulatory Assessments as needed.
Ensures compliance with regulatory agency regulations and interpretations.
Submits responses to regulatory agencies’ questions and other correspondence.
Provides solutions to extreme complex problems.
Engages regulators, when necessary, in oral and written communications to discuss pending or new submissions, regulatory requirements, etc.
Keeps current in regard to US and International regulations, guidance documents, Federal Register notices, and competitor news, and will assist in the development of best practices for Regulatory Affairs processes.
Reviews and approves proposed labeling, packaging, advertising and promotional materials after evaluating conformance to regulations, as needed.
Reviews and provides regulatory authorization related to ongoing product design changes and field action investigations.
How will you get there?
A minimum of a Bachelor’s Degree is required, preferably in a scientific discipline.
Approximate experience of 10+ years in the medical device and/or pharmaceutical industry OR an Advanced Degree and a minimum of 8 years of regulatory experience in the medical device and/or pharmaceutical industry is required. Clinical Chemistry experience is preferred.
Solid knowledge of US FDA regulations and review processes are required.
Practical experience in a medical device Regulatory Environment, preparing US submissions and a successful track record are required.
Technical Documentation experience is required.
Experience interacting with US FDA and other country Regulatory Agencies is required.
Experience in European Union, Asia/Pacific and South American regulations and submissions is preferred.
Excellent written, verbal communication and presentation skills are required, including the ability to communicate clearly, succinctly and effectively over the phone and in writing.
Solid interpersonal skills including the ability to remain calm, professional, diplomatic, and positive are required.
Ability to work as a member of a team in a timeline-driven environment with limited supervision is required.
Being detail-oriented, while having the ability to handle multiple ongoing projects/tasks is required.
- Bachelors and/or Master’s degree in finance, engineering or science. MBA desirable.
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.