7+ years regulated pharmaceutical or medical device experience
Bachelor's degree in physical or life sciences
Authorization to work in the european union
The role supports the creation and submission of product Technical Files for market authorizations in targeted international markets
Job Summary
The role supports the creation and submission of product Technical Files for market authorizations in targeted international markets.
Candidates will lead regulatory strategy development for new products, changes, and manufacturing improvements while ensuring global compliance.
Exact Sciences offers a purpose-driven career with an inclusive culture and robust benefits to support employees helping change cancer detection and treatment.
Matching Summary
The role supports the creation and submission of product Technical Files for market authorizations in targeted international markets.
Skills & Requirements
Must-have
7+ years regulated pharmaceutical or medical device experience
Bachelor's degree in Physical or Life Sciences
Authorization to work in the European Union
Expertise in IVDR, UK CA, FDA and Health Canada regulations
Proficiency in technical writing and regulatory submissions
Nice-to-have
Experience with regulators in Middle East or Latin America
Knowledge of adverse event reporting and post-market surveillance
Ability to work effectively in multinational environments
Strong organizational skills and attention to detail
Experience managing distributors and RA consultants
Key Requirements
7+ years relevant experience in regulated environment
Bachelor's degree in Science or equivalent 5 years experience
Must have authorization to work in the European Union
Work Rights
Authorization to work in the European Union required