Head of Product Development

Head of Product Development
Department:
Operations
Reporting to:
Chief Executive Officer
Location:
Cardiff, Wales, UK
About the Client:
Our client is an innovative and growing company in the medical device industry, dedicated to developing cutting edge products with a focus on wound care.
Job Purpose:
The Head of Product Development will play a crucial role in our client's organisation, overseeing all aspects of product development, from conceptualisation to commercialisation. They will lead cross-functional teams to ensure compliance with regulatory requirements and drive successful product launches.
Key Responsibilities:
Leading the development of medical devices, ensuring compliance with regulatory requirements such as 510(k) and CE mark filings.
Managing product development and translational R&D teams to facilitate the transition of concepts to manufacturing.
Acting as a key stakeholder in engagements with regulatory authorities and notified bodies.
Ensuring compliance with regulatory standards across all platforms and indications.
Documenting product design and development phases according to company procedures.
Collaborating with Quality Management Systems (QMS) to ensure effective documentation and governance.
Developing an optimal data story from preclinical mode of action to clinical endpoints.
Driving key initiatives to increase speed to market and reduce complexity.
Identifying and collaborating with key partners including External Operations, Technical Development, Quality, and Regulatory Affairs.
Leading cross-functional teams to align on end-to-end processes.
Prioritizing continuous improvement and process optimization initiatives.
Qualifications:
Technical BSc degree or higher (MS or PhD) in Engineering, Pharmaceutical Sciences, or similar.
Minimum of 5 years of relevant experience in medical device organizations.
Experience with complete launch of medical devices in the US through the 510(k) filing process.
Strong understanding of regulatory requirements, particularly 510(k) and EU MDR submissions.
Experience in wound care or dermatological medical devices is preferred.
Proficiency in project management and problem-solving skills.
Excellent communication and negotiation skills.
Familiarity with Quality requirements throughout the product lifecycle.
Experience in managing outside vendors and suppliers.
Ability to collaborate effectively with regulatory authorities and notified bodies.
Working Conditions:
This role will be based at our client's headquarters in Cardiff, Wales, UK, and will report directly to the CEO.