7+ years regulated pharmaceutical or medical device experience
Bachelor's degree in life sciences or equivalent experience
Authorization to work in the european union
This role supports the creation and submission of product Technical Files and regulatory strategies for market authorizations in targeted countries
Job Summary
This role supports the creation and submission of product Technical Files and regulatory strategies for market authorizations in targeted countries.
The position requires managing global registrations, reviewing labeling and marketing materials, and ensuring compliance with complex international regulations.
Exact Sciences offers a purpose-driven career in an inclusive culture with robust benefits to support employees helping change cancer detection and treatment.
Matching Summary
Match Score: 85
This role supports the creation and submission of product Technical Files and regulatory strategies for market authorizations in targeted countries.
Skills & Requirements
Must-have
7+ years regulated pharmaceutical or medical device experience
Bachelor's degree in Life Sciences or equivalent experience
Authorization to work in the European Union
Proficiency in IVDR, FDA, Health Canada, and UK CA regulations
Experience managing distributors and RA consultants
Nice-to-have
Experience with regulators in Middle East and Latin America
Strong technical writing skills for regulatory documents
Ability to work effectively in multinational environments
Familiarity with adverse event reporting and post-market surveillance
Professional working knowledge of MLR review processes
Key Requirements
7+ years relevant experience in regulated environment
Bachelor's degree in Physical or Life Sciences
Authorization to work in the European Union
Proficient in Microsoft Office and computer navigation
Ability to travel 30% of working time
Work Rights
Must have authorization to work in the European Union