Our client is a medical device company developing innovative Class III implantable technologies for global markets. As they continue to expand their Regulatory Affairs function, they are seeking a Regulatory Affairs Manager/Senior Specialist to support regulatory strategy and submissions across Europe and the United States.

Working closely with a highly experienced Regulatory Affairs leader, this role offers the opportunity to gain exposure to complex regulatory activities, FDA submissions, and cross-functional product development within a growing organisation.

The role

As Regulatory Affairs Manager/Senior Specialist, you will support regulatory activities across the full product lifecycle, working closely with R&D, Quality, Clinical, and Product Development teams to ensure successful regulatory approvals and market access.

The position is focused on implantable medical devices and will involve significant exposure to FDA regulatory activities. Candidates with experience supporting FDA submissions, including 510(k), PMA, or De Novo pathways, will be highly valued. 

Key responsibilities

• Support the preparation and execution of regulatory submissions, including FDA and international regulatory activities.
• Partner with R&D and engineering teams throughout the design and development process to ensure regulatory requirements are incorporated from an early stage.
• Contribute to regulatory strategy, testing plans, and documentation required for product approvals.
• Support interactions with regulatory authorities and notified bodies.
• Maintain compliance with applicable global regulatory requirements and standards.
• Collaborate across multiple functions to drive successful product development and regulatory outcomes.

Required experience and qualifications

• 5-10 Years of experience within Regulatory Affairs for medical devices within a manufacturer environment.
• Experience supporting FDA regulatory submissions, including exposure to 510(k), PMA, or De Novo pathways. Direct FDA interaction is highly desirable.
• Experience supporting Class III, implantable, active implantable, cardiovascular, neuromodulation, or other highly regulated medical devices.
• Strong understanding of medical device product development and the ability to work closely with R&D teams throughout the development lifecycle.
• A proactive, hands-on mindset with a willingness to take ownership, learn, and grow within the organisation.

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.