Job Description
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.
#J-18808-Ljbffr