Regulatory Affairs Specialist II | Costa Rica

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.

Position Responsibilities:

• Coordinate, compile, and submit regulatory filings for new and modified products to Costa Rica and Central America Health Authorities.
• Review of product and manufacturing changes for compliance with applicable regulations and impact to regulatory filings;
• Monitor and assess regulatory updates for compliance with applicable regulations and impact to regulatory filings, communicate relevant changes to internal stakeholders.
• Collaborate cross-functionally with global and regional RA counterparts, legal representatives, commercial, marketing, and operations teams to ensure aligned execution of regulatory priorities and approvals.
• Maintain current and accurate information in regulatory systems regarding status, approvals, and product licenses.
• Develops and maintains positive relationships with regulatory agencies and industry associations through verbal and written communications.
• Coordinates localization process to guarantee Costa Rica and Central America labeling requirements are met.
• Provide regulatory input on promotional, labeling, and advertising materials in line with Central America regulations.
• Serve as the RA point of contact for consultants and distributors to ensure accurate and compliant submissions.

Required Qualifications:

• 3-5 years of experience as a Regulatory Affairs Specialist in medical devices in Costa Rica and Central America countries.
• Knowledge of Central American regulations.
• Bachelor’s degree in Life Sciences (Pharmacy, Biochemistry, Biomedical Engineering or associated areas);
• Advanced English;
• Attention to detail and ability to identify trends, gaps etc.
• Problem-solving skills;
• Ability to communicate complex ideas clearly and simply both verbally and in writing;
• Ability to effectively manage multiple projects and priorities;
• Team player with excellent interpersonal skills.

Preferred Qualifications:

• General knowledge of global or LATAM regulations is an asset.
• Experience with interactions with regulators: Regulatory Intelligence and Advocacy.

Requisition ID: 613536

As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.

So, choosing a career with Boston Scientific (NYSE: BSX) isn’t just business, it’s personal. And if you’re a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you!