Regulatory Affairs Specialist

Our client is a rapidly growing medical technology company headquartered in Iceland, developing advanced wound care solutions to transform the treatment of surgical wounds, chronic wounds, burns, oral ulcers, and internal tissue repair. With rapid clinical adoption, regulatory approvals underway, and global expansion planned, they are entering a new phase of growth and are looking to hire two Regulatory Affairs Specialists to take a key role in shaping their regulatory strategy. The roleAs Regulatory Affairs Specialist, you will be responsible for leading and executing regulatory submissions in key markets, including Europe and the US.

Reporting to senior leadership, you will prepare technical documentation, compile registration data, and provide regulatory input during development projects. You will ensure compliance with EU MDR and FDA 510(k) requirements, supporting market entry and expansion for innovative wound care products. This is a hands-on role based in Reykjavík, Iceland, and relocation is required. Full relocation support is provided. Key responsibilitiesPrepare and submit regulatory filings, including EU MDR, FDA 510(k), and other international registrations. Compile and maintain technical documentation for product registrations. Provide regulatory input during development projects to guide design and clinical strategies.

Collaborate with clinical and R&D teams to ensure compliance with regulatory requirements. Support market entry and expansion activities from a regulatory perspective. Required experience and qualificationsUniversity degree in a relevant scientific or engineering discipline. Experience in medical device registration is an advantage. Familiarity with EU MDR and/or FDA regulatory frameworks. Strong technical writing and documentation skills. Excellent communication and collaboration abilities. Willingness to relocate to Iceland (relocation support provided). Your consultantAs a Recruitment Consultant at Aspire Life Sciences, Taylor Lyons specialises in Quality and Regulatory Affairs recruitment across the MedTech and pharmaceutical sectors in Europe.

Taylor works closely with high-growth companies to identify and engage experienced professionals who can drive compliance, innovation, and operational excellence. With a deep understanding of the regulatory landscape and industry demands, Taylor focuses on building long-term partnerships that deliver real impact.