Regulatory Affairs Specialist III | Costa Rica
Boston Scientific · Escazú
Additional Locations: N/A
Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance
At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions.
About the role
The Regulatory Affairs Specialist III develops and executes regulatory strategies for assigned product portfolios across Costa Rica and Central America. The role supports timely product approvals, continued compliance, business continuity, and effective regulatory risk management. This position works closely with global and LATAM partners, health authorities, and industry stakeholders to anticipate regulatory challenges, provide clear guidance, and help shape a favorable regulatory environment. It also contributes to continuous improvement and digital transformation initiatives while offering broad regional exposure and opportunities to solve complex regulatory matters.
Your responsibilities will include
- Develop local strategies for regulatory approval in collaboration with Marketing, Planning, and International Division teams.
- Coordinate, compile, and submit regulatory filings for new and modified products to health authorities in Costa Rica and Central America.
- Review product and manufacturing changes for compliance with applicable regulations, determine their impact on regulatory filings, and recommend appropriate regulatory actions.
- Monitor and interpret regulatory developments, assess their potential impact on products and regulatory activities, and provide clear, timely recommendations to internal stakeholders.
- Lead cross-functional coordination with global RA, commercial, marketing, and operations teams to align priorities, resolve complex issues, and enable timely regulatory approvals.
- Maintain current and accurate information in regulatory systems regarding status, approvals, and product licenses.
- Develop and maintain professional relationships with health authorities and industry associations through effective verbal and written communication.
- Coordinate localization activities to ensure that labeling meets applicable requirements in Costa Rica and Central America.
- Review and provide regulatory input on promotional, labeling, and advertising materials in accordance with applicable Central American regulations.
- Serve as the RA point of contact for consultants and distributors to ensure accurate and compliant submissions.
Required Qualifications:
- 3–5 years of Regulatory Affairs experience with medical devices in Costa Rica and Central American markets.
- Bachelor’s degree in Life Sciences or a related field, such as Pharmacy, Biochemistry, or Biomedical Engineering.
- Demonstrated experience preparing, coordinating, and managing medical device regulatory submissions.
- Strong knowledge of medical device regulations and submission requirements in Central America.
- Advanced English proficiency, with the ability to communicate effectively in regional and global business settings.
- Experience interacting with health authorities and supporting regulatory intelligence, advocacy, or policy activities.
- Ability to analyze and interpret scientific information, business materials, and government regulations.
- Strong attention to detail and the ability to identify trends, gaps, and regulatory risks.
- Ability to manage regulatory information accurately in databases and business systems.
- Strong written and verbal communication skills, including the ability to translate complex regulatory information into clear, actionable guidance.
- Strong interpersonal, collaboration, problem-solving, and project-prioritization skills.
Preferred Qualifications:
- General knowledge of global or LATAM regulations is an asset.
- Experience interacting with health authorities and supporting regulatory intelligence and advocacy activities.
Requisition ID: 634183
Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 45 years, we advance science for life by providing a broad range of high-performance solutions that address unmet patient needs and reduce the cost of healthcare. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions. Learn more at www.bostonscientific.com and follow us on LinkedIn.