Regulatory Affairs Specialist
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.?xml:namespace prefix = "o" /
The Regulatory Affairs Specialist obtains medical device pre-market regulatory approvals and necessary domestic listings to ensure global market access is realized for products and services. This individual will author and maintain regulatory submission in the US, Canada, Europe and works through third party entities in the rest of the world. In addition they'll provide Regulatory Affairs support on new product development projects. This individual must be vigilant of developing standards and regulations and their impact on product regulatory status. In addition, the RA Specialist will also handle post-market agency reporting activities i.e. Medical Device Reports, Correction & Removal Reporting and Post Market Surveillance.
- Prepare, submit, and manage regulatory clearance applications required for product market approvals in the US and Canada as necessary
- Submit and manage domestic product listings
- Prepare, submit, manage and maintain European Technical Files in compliance with the requirements of the MDD/IVDD and the Quality Management System
- Function as a Regulatory Affairs subject matter expert on new product introduction and engineering design control teams
- Assist research personnel, application specialists, risk management specialist, to ensure clinical research and clinical evaluation are performed in accordance with necessary regulatory requirements
- Lead post market surveillance activity including assembling necessary evidence and prepare Summary reports, as appropriate
- Participate as subject matter expert in internal and external quality system and design dossier audits
- Lead and complete labeling reviews and provide feedback to Commercial team
- Gather and prepare materials to enable MDR, Vigilance, AE, Recall, etc. decision making process
- Collate and prepare all materials, reports and follow-up with Regulatory Agencies regarding recall activity
- Co-ordinate international device reporting with regional representatives
- May prepare documentation and reports after interpretation of federal, state, and/or international regulations for submission to other units of the company, customers, governmental regulatory agencies, etc.
- BA/BS degree is required. Preferred education/experience areas include clinical, engineering, physical science, biological, and regulatory sciences preferred.
- A minimum of 5 years’ experience in regulatory and/or quality assurance in a medical device development and manufacturing environment (IVD a plus).
- Solid working knowledge of the global regulations and standards applicable to medical device market clearance.
- Proven track record of supporting medical devices to market in multiple regions including US, Canada, Europe.
- Proficiency in working through third parties to obtain market clearance in other countries.
- Ability to flexibly work with cross functional teams on multiple parallel projects, pro-active, drive for improvement
- Excellent verbal and written communications skills; strong attention to detail and excellent organization skills
- Experience in project management preferred
At Thermo Fisher Scientific, each one of our 55,000 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.
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.