Senior regulatory affairs specialist

?? We're Hiring: Senior Regulatory Affairs Partner | Medical Devices

Are you an experienced Regulatory Affairs professional looking to take the next step in your career and play a strategic role in bringing innovative medical devices to global markets?
We are seeking a Senior Regulatory Affairs Partner to join a growing team in Coyol Free Trade Zone, Costa Rica.
?? What you'll do:

• Lead global regulatory submissions for new and existing medical devices
• Develop and execute regulatory strategies for key international markets
• Partner closely with Engineering, Quality, and Product Development teams
• Ensure compliance with FDA and EU MDR/IVDR requirements
• Support product lifecycle management and post-market regulatory activities
• Act as a trusted regulatory advisor across the organization
?? What we're looking for:

? 5+ years of Regulatory Affairs experience within the Medical Device industry
? Strong knowledge of FDA regulations and EU MDR/IVDR
? Experience with regulatory submissions and compliance activities
? Understanding of Design Controls and product lifecycle requirements
? Advanced English communication skills
? U.S. Visa preferred
?? Location: Coyol Free Trade Zone, Costa Rica
?? Benefits include:

• Private medical insurance
• Life insurance
• Asociación Solidarista
• Meal subsidy
• Transportation subsidy (subject to route availability)
• Paid birthday leave
• Additional seniority leave
• International exposure and occasional travel opportunities
This is an excellent opportunity to influence regulatory strategy, collaborate with global teams, and contribute directly to the successful launch and maintenance of impactful medical devices.
?? Interested or know someone who could be a great fit? Feel free to reach out to *********@***************.***

Profesional

Bachillerato universitario

Ingenierías Otras

4 años de experiencia

1 Vacante