Senior Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist

Location: Alajuela, Costa Rica 
Function: Quality & Regulatory Affairs
Hybrid position

About the Role 

We’re searching for a Senior Regulatory Affairs Specialist to help bring medical devices to market and keep them compliant throughout their lifecycle. This role is critical to ensuring our products meet global regulatory requirements while supporting new product development and ongoing operations.

You’ll work cross-functionally with engineering, quality, and external partners to manage submissions, maintain approvals, and drive smarter regulatory strategies.  This is an excellent opportunity to work on impactful medical products and collaborate with global teams across engineering, product development, quality, and regulatory.  The successful candidate will play a key role in shaping regulatory strategy and product success, with the opportunity to grow into broader leadership responsibilities over time.

What You’ll Do

• Lead and support global regulatory submissions for new and existing products
• Prepare and manage technical documentation and registration dossiers
• Partner with product development teams to ensure regulatory compliance from design through launch
• Maintain regulatory filings, labeling, and product documentation
• Manage post-market regulatory activities (reports, updates, inquiries)
• Coordinate with health authorities and notified bodies on submissions and responses
• Track regulatory changes and recommend faster approval strategies
• Support engineering changes to ensure ongoing compliance. 
• Leverage your experience and act as a trusted resource for internal teams and less experienced colleagues

What Success Looks Like

• Successful and timely product registrations across key markets
• Strong regulatory strategies that reduce approval timelines
• Clear, accurate, and audit-ready documentation
• Smooth collaboration across teams and external partners

What You Bring

• 5+ years of direct Regulatory Affairs experience in the medical device industry, including hands-on involvement in regulatory submissions and compliance activities.
• Direct experience applying U.S. FDA and European (EU MDR/IVDR) medical device regulations, preferably for Class II/III devices.
• Advanced understanding of design controls and product lifecycle requirements
• Strong project management and cross-functional collaboration skills
• Excellent written and verbal communication skills in English(C1) 

Why Join Us

• Take the next step in your Regulatory Affairs career by moving into a more strategic role with increased ownership, influence, and impact on bringing medical devices to market.
• Collaborate with global teams across engineering, quality, and regulatory
• Play a key role in shaping regulatory strategy and product success
• Opportunity to influence both process improvements and project outcomes