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Head of Product Development and Innovation
2 months ago
We are seeking a highly skilled and experienced Head of Product Development 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 and ensuring compliance with regulatory requirements.
Key Responsibilities- Product Development Leadership: Lead cross-functional teams to develop medical devices, ensuring compliance with regulatory requirements such as 510(k) and CE mark filings.
- Team Management: Manage product development and translational R&D teams to facilitate the transition of concepts to manufacturing.
- 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.
- Documentation and Governance: Document product design and development phases according to company procedures and collaborate 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.
- Process Optimization: Drive key initiatives to increase speed to market and reduce complexity, and prioritize continuous improvement and process optimization initiatives.
- 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.
- Project Management: Proficiency in project management and problem-solving skills, with excellent communication and negotiation skills.
- Quality Requirements: Familiarity with Quality requirements throughout the product lifecycle, and experience in managing outside vendors and suppliers.
This role will be based at our headquarters in Cardiff, Wales, UK, and will report directly to the CEO. As a key member of our team, you will have the opportunity to work with a talented group of professionals and contribute to the development of innovative medical devices that improve patient outcomes.
