Join our team and make a difference by aiding customers in finding cures for cancer, protecting the environment, or ensuring food safety. Your work will have a tangible impact, and we will support your career ambitions!
How will you make an impact:
Thermo Fisher is hiring a Regulatory Affairs Manager for in vitro diagnostics. They will provide support to In-Vitro Diagnostic core teams. The manager will handle regulatory activities including drafting and reviewing sPMA's, pre-submissions, and other filings. They will also assist with publishing, document legalization, and communication with regulatory agencies.
What will you do:
Prepare, collect, or coordinate information and prepare regulatory documentation for submission to regulatory agencies or commercial partners
Perform regulatory assessments of new and changed products
Provide regulatory support to existing and new cross-functional product teams and serve as the regulatory core team lead for companion diagnostic programs and other new products.
Participate in project activities and review key project documents such as product design protocols related to verification and validation, risk assessment, etc.
Author 510(k), PMA, PMA supplement, and pre-submissions.
Help prepare ex-US registrations and work with Regulatory Affairs colleagues in other regions to provide registration documents for IVD products promptly.
Stay ahead of new or revised regulations, guidelines, points to consider, compliance guides, inspection reports, journals, meetings, etc.
How will you get here:
A minimum B.S. degree in Biology, Chemistry, bio-engineering or a related science, or equivalent experience.
Experience in Next Generation Sequencing (NGS), Companion diagnostic (CDx), and Oncology.
Experience:
A minimum of 4 years within a technical environment; Regulatory Affairs, Quality Assurance, Software/System engineering, or R&D experience preferred.
Must have familiarity in the aspects of regulatory submissions, design control, and cGMP/Quality Systems.
Demonstrate in-depth understanding of technical/scientific principles related to IVD reagent chemistry, laboratory automation, and software components of IVD medical devices.
Previous experience authoring regulatory filings and pre-submissions preferred.
Capacity to communicate regulations to technical functions within the company.
Communicate with regulatory agencies and lead FDA meetings.
Required Qualifications:
Excellent communicator
Hands-on, productive, and able to implement optimally through their team
Continuous improvement-minded; familiar with balancing the need for quality and efficiency
Able to work autonomously in a matrix-managed organization
