Senior Regulatory Affairs Specialist in Alajuela, Alajuela at Theragenics Corp

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 productsPrepare and manage technical documentation and registration dossiersPartner with product development teams to ensure regulatory compliance from design through launchMaintain regulatory filings, labeling, and product documentationManage post-market regulatory activities (reports, updates, inquiries)Coordinate with health authorities and notified bodies on submissions and responsesTrack regulatory changes and recommend faster approval strategiesSupport 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 marketsStrong regulatory strategies that reduce approval timelinesClear, accurate, and audit-ready documentationSmooth 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 requirementsStrong project management and cross-functional collaboration skillsExcellent 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 regulatoryPlay a key role in shaping regulatory strategy and product successOpportunity to influence both process improvements and project outcomes