Senior Product Manager

7 days ago


Cardiff, Cardiff, United Kingdom Hlx Life Sciences Full time

Job Summary:

Hlx Life Sciences is seeking a highly skilled and experienced Head of Product to lead our product development efforts. As a key member of our team, you will be responsible for overseeing all aspects of product development, from conceptualization to commercialization.

Key Responsibilities:

  • Lead cross-functional teams to ensure compliance with regulatory requirements and drive successful product launches.
  • Develop and implement product development strategies that align with company goals and objectives.
  • Collaborate with internal stakeholders, including External Operations, Technical Development, Quality, and Regulatory Affairs, to ensure effective product development and launch.
  • Manage product development and translational R&D teams to facilitate the transition of concepts to manufacturing.
  • Act as a key stakeholder in engagements with regulatory authorities and notified bodies.
  • Ensure compliance with regulatory standards across all platforms and indications.
  • Document product design and development phases according to company procedures.
  • Collaborate with Quality Management Systems (QMS) to ensure effective documentation and governance.
  • Develop an optimal data story from preclinical mode of action to clinical endpoints.

Requirements:

  • 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.

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