Head of Product Development
2 weeks ago
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.
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