Lead Regulatory Affairs Manager, International

Exact Sciences Corporation

Multiple Locations
**
Technical files/standard technical documentation
Regulatory strategy development
Global regulatory affairs procedures
** Exact Sciences Corporation is seeking a Lead Regulatory Affairs Manager, International, to oversee regulatory submissions and strategies for market authorizations of medical devices. The ideal candidate will have extensive experience in regulatory affairs within a pharmaceutical or medical device environment, focusing on compliance and effective communication across multinational teams. **

Job Summary

  • At Exact Sciences, we’re helping change how the world prevents, detects and guides treatment for cancer.
  • The Lead Regulatory Affairs Manager, International will support or lead the creation and submission of product Technical Files/Standard Technical Documentation and other submission related documents for market authorizations in targeted markets and countries.
  • Our success relies on the experiences and perspectives of a diverse team, and Exact Sciences fosters a culture where all employees can develop personally and professionally with a sense of respect and belonging.

Matching Summary

Match Score: 75

** Exact Sciences Corporation is seeking a Lead Regulatory Affairs Manager, International, to oversee regulatory submissions and strategies for market authorizations of medical devices. The ideal candidate will have extensive experience in regulatory affairs within a pharmaceutical or medical device environment, focusing on compliance and effective communication across multinational teams. **

Skills & Requirements

Must-have

  • Technical Files/Standard Technical Documentation
  • Regulatory strategy development
  • Global regulatory affairs procedures
  • Regulatory compliance review
  • Product labeling and marketing material review
  • IVDR, UK CA, FDA, Health Canada regulations

Nice-to-have

  • Experience in Middle East and/or Latin America
  • Professional working knowledge with adverse event reporting
  • Post-market surveillance and vigilance requirements
  • Ability to work effectively in multinational/multicultural environments

Key Requirements

  • Bachelor’s degree in Physical or Life Sciences or equivalent experience
  • 7+ years relevant experience in regulated pharmaceutical or medical device
  • Authorization to work in the European Union
  • Strong technical writing skills
  • Exceptional attention to detail
  • Strong organizational skills

Work Rights

Authorization to work in the European Union

Tailored Resume

Cover Letter