About this role

Identify key regulatory submission deliverables and contribute to the development of a project master schedule
Prepare regulatory submissions including formal written technical reports
Provide regulatory leadership to new product development teams to advise on impact of product or business decisions
Provide regulatory training to cross-functional groups
Actively manage and monitor submissions under review
Respond promptly and negotiate with regulatory authorities, as needed
Track and manage regulatory review timelines

Bachelor’s degree in field with 5+ years of related work experience OR Master's degree in field with 3+ years of related work experience OR Doctoral degree in field with 0-2 years of related work experience
In depth understanding of Regulatory Affairs concepts and familiarity with regulations/guidelines governing development of diagnostic products
Experience supporting 510k submissions required
Ability to prioritize, multi-task, and organize work
Detail oriented with good analytical skills
Ability to succeed in a fast-paced environment

Senior Regulatory Affairs Specialist, New Product Development

Key skills