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Head of Product Development

2 months ago

Cardiff, Cardiff, United Kingdom Hlx Life Sciences Full time
Job Description

Head of Product Development

Hlx Life Sciences is seeking a highly skilled and experienced Head of Product Development 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 our company's goals and objectives.
  • Collaborate with our regulatory affairs team to ensure compliance with regulatory standards across all platforms and indications.
  • 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.
  • Develop an optimal data story from preclinical mode of action to clinical endpoints.
  • Identify and collaborate with key partners, including External Operations, Technical Development, Quality, and Regulatory Affairs.

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.