Head of Product Development

3 weeks ago

Cardiff, United Kingdom Hlx Life Sciences Full time

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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