When youre part of Thermo Fisher Scientific, youll do challenging work, and be part of a team that values performance, quality and innovation. As part of a successful, growing global organization you will be encouraged to perform at your best. With revenues of $20 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.
Thermo Fisher Scientific is currently recruiting for a Senior Regulatory Specialist who will join the Regulatory Affairs, Clinical & Compliance Team.
As a Senior Regulatory Specialist you will be responsible for managing In-Vitro Diagnostic (IVD) Medical Device regulatory submissions and regulatory compliance activities in line with corporate and divisional objectives. In addition, the position will provide regulatory support to customers with respect to legislative requirements for the market place, mainly EMEA.
What will you do?
As a Senior Regulatory Specialist you will:
Compile, review and maintain regulatory submissions, Technical Files, and labelling for completeness and quality
Identify regulatory requirements for new product and changes to existing products
Contribute within new product development projects to ensure compliance with internal product commercialization process (PCP) and global regulations
Review and approve product labelling/marketing materials for compliance with applicable regulations and standards
Review new and existing regulations, guidance documents and standards, and prepare comments based on impact to product and business
Support post-market surveillance and vigilance activities
Participate in internal and external company regulatory/quality audits, and assist corporate in carrying out GMP cross-site audits
Participate in customer audits/technical meetings when applicable
Develop regulatory affairs internal policies and procedures, and provide internal trainings as and when required
How will you get here?
Bachelors degree in Biology or similar field, from an accredited college or university or equivalent experience
Experience and Knowledge/Skills/Abilities
Strong working knowledge of In-Vitro Diagnostic/Medical Device regulatory affairs environment including but not exclusive to: Regulations, Submissions and Technical Files
Experience of communicating with Regulatory Authorities and Distributors
Experience in clinical trials, specifically regulatory activities and submissions for the trials
Experience in regulatory audits, ISO certification, GMP requirements and document control
At Thermo Fisher Scientific, each one of our 65,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular missionenabling our customers to make the world healthier, cleaner and safer.
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.