Supervisor, Regulatory Affairs
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Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
Work Schedule
Standard (Mon-Fri)Environmental Conditions
OfficeJob Description
As part of the Thermo Fisher Scientific team youll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the worlds toughest challenges like protecting the environment making sure our food is safe or helping find cures for cancer.
Description
This role is responsible for leading the regulatory market access team driving complex global regulatory submissions for IVD and Medical Device portfolios. This role includes defining strategic regulatory pathways mentoring junior team members and partnering with internal and external stakeholders to ensure regulatory compliance and successful market access worldwide.
Responsibilities
- Lead development and execution of global regulatory strategies for product registrations renewals and change controls across major markets.
- Prepare review and submit regulatory dossiers under MDR IVDR and other regional frameworks (APAC LATAM EMEA etc.).
- Manage end-to-end submission lifecycle including gap analysis remediation application tracking and response coordination.
- Partner closely with R&D Quality and Manufacturing teams to ensure regulatory input into design and development documentation.
- Coordinate directly with Notified Bodies and health authorities to resolve queries and facilitate timely approvals.
- Maintain and update regulatory documentation and databases for global portfolio maintenance.
- Provide guidance to regional teams on requirements formats and timelines to ensure execution consistency.
- Support labeling reviews product change assessments and post-market compliance activities.
- Identify process improvement opportunities within submission preparation and document management workflows.
- Manage regulatory specialists through on-the-job training and review of deliverables to meet business goals.
- Maintain accurate and up-to-date regulatory documentation and records.
- Ensure proper documentation practices are followed in accordance with regulatory standards.
Qualification & Experience
- Minimum 12 years of experience in global Regulatory Affairs for IVDs and Medical Devices.
- Proven track record in hands-on submission execution and authority communication.
- Strong understanding of MDR IVDR FDA 510(k)/PMA and other regional product registration pathways.
- Experience managing simultaneous submissions across multiple geographies.
- Early leadership experience preferred.
- Excellent technical writing analytical and cross-functional collaboration skills.
- Degree in Life Sciences Regulatory Affairs or Biomedical Engineering; advanced degree preferred.
- Proficiency in digital submission platforms and document control systems.
- Capability to balance strategic planning with day-to-day regulatory execution.
Required Experience:
Manager
Key Skills
About Company
Electron microscopes reveal hidden wonders that are smaller than the human eye can see. They fire electrons and create images, magnifying micrometer and nanometer structures by up to ten million times, providing a spectacular level of detail, even allowing researchers to view single a ... View more
