Product Development Director

6 days ago

Cardiff, Cardiff, United Kingdom Hlx Life Sciences Full time
About the Role

We are seeking a highly skilled and experienced Product Development Director to join our team at Hlx Life Sciences. As a key member of our organization, you will play a crucial role in driving the development of cutting-edge medical devices.

Key Responsibilities
  • Product Development Leadership: Oversee all aspects of product development, from conceptualization to commercialization, ensuring compliance with regulatory requirements.
  • Team Management: Lead cross-functional teams to facilitate the transition of concepts to manufacturing, ensuring effective documentation and governance.
  • Regulatory Compliance: Act as a key stakeholder in engagements with regulatory authorities and notified bodies, ensuring compliance with regulatory standards across all platforms and indications.
  • Product Design and Development: Document product design and development phases according to company procedures, collaborating with Quality Management Systems (QMS) to ensure effective documentation and governance.
  • Data Storytelling: Develop an optimal data story from preclinical mode of action to clinical endpoints, driving key initiatives to increase speed to market and reduce complexity.
  • Process Optimization: Prioritize continuous improvement and process optimization initiatives, leading cross-functional teams to align on end-to-end processes.
Requirements
  • Technical Expertise: Technical BSc degree or higher (MS or PhD) in Engineering, Pharmaceutical Sciences, or similar.
  • Industry Experience: Minimum of 5 years of relevant experience in medical device organizations, with experience in wound care or dermatological medical devices preferred.
  • Regulatory Knowledge: Strong understanding of regulatory requirements, particularly 510(k) and EU MDR submissions.
  • Leadership Skills: Excellent communication and negotiation skills, with the ability to collaborate effectively with regulatory authorities and notified bodies.
Working Conditions

This role will be based at our headquarters in Cardiff, Wales, UK, and will report directly to the CEO.

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