Regulatory Affairs Manager LATAM
HologicSão Paulo, Brazil
Posted March 12, 2026
Full Time
About the Company
Hologic is an innovative medical technology company dedicated to enabling healthier lives through groundbreaking products and services. Specializing in Breast & Skeletal Health, Diagnostic Solutions, and GYN Surgical Solutions, the company excels in early detection and treatment of health conditions, driven by a commitment to women's health and a focus on clinical superiority. Hologic fosters a culture of expertise, dedication, and continuous improvement to meet unmet health needs globally.
Job Description
Regulatory Affairs Manager, LATAM position at Hologic, responsible for driving regulatory strategy across the region and collaborating with cross-functional colleagues.
Requirements
- Minimum 7 years of relevant experience in Regulatory Affairs and Quality Assurance within the medical device and/or IVD industry.
- Strong knowledge of LATAM regulatory requirements for medical devices and/or IVDs, with a proven track record of successful registrations, submissions, and approvals in the region.
- Good understanding of EU MDR / IVDR and US FDA regulations and how they interface with global regulatory strategies.
Benefits
- Competitive salary
- Annual bonus scheme
- Continued development opportunities
