Regulatory Affairs Specialist III – Costa Rica

About the role

The Regulatory Affairs Specialist III will develop and execute regulatory strategies for Boston Scientific’s product portfolio across Costa Rica and Central America. The role ensures timely product approvals, maintains compliance, and manages regulatory risk while collaborating with global and regional partners and health authorities.

Key responsibilities

• Develop local regulatory approval strategies in collaboration with marketing, planning and international teams.
• Coordinate, compile and submit regulatory filings for new and modified medical devices to health authorities in Costa Rica and Central America.
• Review product and manufacturing changes for regulatory compliance and determine impact on filings.
• Monitor regulatory developments, assess their impact and provide timely recommendations.
• Lead cross‑functional coordination with global RA, commercial, marketing and operations teams to ensure timely approvals.
• Maintain accurate information in regulatory systems regarding status, approvals and licenses.
• Build and maintain professional relationships with health authorities and industry associations.
• Ensure labeling and promotional materials meet regional regulatory requirements.
• Act as the regulatory affairs point of contact for consultants and distributors.

Required profile

• 3–5 years of regulatory affairs experience with medical devices in Costa Rica and Central America.
• Bachelor’s degree in Life Sciences, Pharmacy, Biochemistry, Biomedical Engineering or a related field.
• Proven experience preparing, coordinating and managing medical device regulatory submissions.

Required skills