Regulatory Affairs Manager

at  Thermo Fisher Scientific

JOB DESCRIPTION

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!

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
• Ability to travel (~10-15%)
• Able to deal with ambiguity and change

• 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.