Vice President, Regulatory & Clinical Affairs (Orthopaedic/Medical Device) Location: Galway, Ireland / US East Coast
Reports To: CEO
Department: Regulatory Affairs & Clinical Affairs

The VP of Regulatory & Clinical Affairs will lead regulatory and clinical strategies for the development, approval, and commercialization of orthopaedic medical device products. This role is responsible for regulatory submissions, clinical trial design, compliance with global regulations (FDA, MDR, ISO 13485), and interactions with regulatory agencies. The VP will collaborate cross-functionally to ensure regulatory and clinical initiatives align with the company’s business objectives and market access strategies.

Regulatory Affairs

• Develop and execute global regulatory strategies for Class II and Class III orthopaedic implants & surgical instruments.
• Lead regulatory submissions (510(k), De Novo, CE Mark, IDE) and ensure timely product approvals.
• Serve as the primary liaison with global regulatory agencies, managing pre-submissions, meetings, and responses.
• Monitor evolving regulatory requirements (e.g., EU MDR, ISO 13485, FDA QSR, MDSAP) and implement compliance strategies.
• Oversee post-market regulatory compliance, including adverse event reporting, labelling, and vigilance reporting.
• Provide guidance on UDI (Unique Device Identification) and regulatory intelligence.
• Collaborate with R&D, Quality, and Manufacturing on design control, risk management, and regulatory labelling.

Clinical Affairs

• Design and oversee EU/MDR and US/FDA based clinical trials for orthopaedic implants and surgical instruments.
• Develop and execute clinical study protocols, site selection, investigator training, and data collection.
• Ensure compliance with Good Clinical Practice (GCP), ISO 14155, and FDA IDE regulations.
• Lead interactions with surgeons, key opinion leaders (KOLs), and clinical investigators to support product development.
• Manage clinical data analysis and reporting for regulatory submissions, publications, and marketing approvals.
• Oversee post-market clinical follow-up (PMCF) studies required under MDR regulations.

Leadership & Cross-Functional Collaboration

• Report directly to the CEO as a key member of the company Senior Leadership Team (SLT).
• Visibility and accountability to the Board and other stakeholders.
• A leader/doer mindset – ability to ‘roll up the sleeves’ as part of a small start-up team with the dual ability to zoom out and provide strategic direction.
• Lead and mentor the Regulatory & Clinical Affairs teams, fostering a high-performance culture.
• Collaborate with R&D, Quality, Marketing, and Commercial teams to integrate regulatory and clinical considerations.
• Provide executive leadership with regulatory risk assessments, approval timelines, and strategic recommendations.
• Represent the company at industry conferences, regulatory workshops, and professional organizations.
• Support other functions including sales and marketing.
• Participate in focus group discussions, including risk/benefit analyses.

• Degree (BSc, BEng, MS, PhD) in Engineering, Regulatory Affairs, or a related field.
• 12+ years of regulatory and clinical experience in the medical device industry.
• Proven success in leading 510(k), IDE, and CE Mark approvals for Class II and/or Class III devices.
• Deep knowledge of FDA regulations, EU MDR, ISO 13485, MDSAP, and other international regulatory environments & requirements.
• Experience in clinical trial design, execution, and regulatory interactions for implants.
• Strong understanding and/or relationships with FDA CDRH and notified bodies.
• Exceptional leadership, strategic thinking, and communication skills.

• Experience with orthopaedic implants or other complex medical devices requiring deep interaction with transnational regulatory authorities.
• Prior experience leading regulatory and clinical functions – ideally with both large company experience and demonstrated ability to transfer to a start-up setting.

• Overall, this role offers the candidate the opportunity to design, manage, grow, and lead within a small organization with the ambitions, plans, and funding necessary to grow quickly into a new market within our field of orthopaedics.
• The VP role offers unparalleled personal and professional development opportunities within a strong, positive cultural work environment.
• This is a full-time executive role that carries an attractive package, including a market-leading salary, profit sharing (approved ESOP), and a benefits package with options for pension, healthcare, short- and long-term sickness support, and death-in-service provisions.
• You will work in a supportive and collaborative environment that affords flexibility and a hybrid workplace.

To find out more please get in touch via email: dd@dd.com