Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
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!
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.
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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
- Ability to travel (~10-15%)
- Able to deal with ambiguity and change