International Regulatory Affairs Specialist

About the job

Our client is an established medical device company based in Odense, Denmark, developing innovative medical technologies for international markets. As they continue to expand their Regulatory Affairs capabilities, they are seeking an International Regulatory Affairs Specialist with strong FDA experience to support regulatory submissions and technical documentation across the product development lifecycle.

This is an excellent opportunity for a regulatory professional who wants to work closely with product development teams and take an active role in bringing innovative medical devices to the US and international markets.

The role

As an International Regulatory Affairs Specialist, you will play a key role in developing and executing regulatory strategies for medical devices across international markets, with a particular focus on the United States and FDA submissions.

You will work closely with R&D, Quality, Clinical, Engineering, and other cross-functional teams to ensure that the required regulatory and technical documentation is developed throughout the product lifecycle.

A significant part of the position will involve preparing and supporting FDA submissions, including De Novo applications, alongside the development and maintenance of comprehensive technical documentation such as Design History Files, clinical documentation, verification and validation documentation, and product testing records.

Key responsibilities

• Develop and support regulatory strategies for medical devices across international markets, with a strong focus on the US FDA.
• Prepare, coordinate, and support FDA regulatory submissions, including De Novo applications.
• Compile, write, review, and maintain regulatory and technical documentation throughout the product development lifecycle.
• Support the development and maintenance of Design History Files (DHF) and associated design control documentation.
• Review and coordinate clinical documentation, verification and validation documentation, test reports, risk documentation, and other technical records required for regulatory submissions.
• Work closely with Engineering, R&D, Clinical, Quality, and other stakeholders to ensure regulatory requirements are incorporated into product development activities.
• Support interactions with regulatory authorities and contribute to responses to regulatory questions and requests for additional information.
• Monitor changes to international regulatory requirements and assess their impact on existing and future products.
• Support regulatory activities throughout the complete product lifecycle, from early development through market approval and post-market changes.

Required experience and qualifications

• Several years of experience within Regulatory Affairs for medical devices.
• Strong practical knowledge of FDA regulations and US medical device approval pathways.
• Previous hands-on experience preparing or contributing significantly to FDA submissions.
• Experience writing, reviewing, and maintaining comprehensive technical documentation, including Design History Files (DHF), design control documentation, clinical documentation, verification and validation records, and product testing documentation.
• Good understanding of medical device product development and the regulatory requirements associated with bringing new technologies to market.
• Experience working closely with multidisciplinary teams across Engineering, R&D, Quality, and Clinical functions.
• Degree in a scientific or technical discipline such as Biomedical Engineering, Engineering, Life Sciences, or a related field.
• Strong written and spoken English communication skills.
• Experience with De Novo submissions would be highly advantageous; however, candidates with strong FDA submission experience and the ability to support future De Novo applications will also be considered.
• Ability to work independently, manage multiple regulatory activities, and communicate effectively with both technical and non-technical stakeholders.

Your consultant

As a Recruitment Consultant at Aspire Life Sciences, Taylor Lyons specialises in technical and executive hiring across Medical Devices, Neurotechnology, AI, and DeepTech. Taylor partners with venture-backed startups, scale-ups, and global medical device organisations to identify exceptional talent across Regulatory Affairs, Quality, Clinical, Engineering, and leadership functions throughout Europe, North America, and Asia.