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Head of Product

2 months ago

Cardiff, United Kingdom Hlx Life Sciences Full time

Head of Product Development Department: 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.

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.

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.
Identifying and collaborating with key partners including External Operations, Technical Development, Quality, and Regulatory Affairs.
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.
Familiarity with Quality requirements throughout the product lifecycle.
Ability to collaborate effectively with regulatory authorities and notified bodies.