Director of Regulatory Affairs and Quality Assurance

Shape the Face of Cancer Treatment at Luminate Medical

Our vision is to build innovative new products which revolutionise the patient experience of cancer treatment. Our first product is a wearable medical device to prevent hair loss caused by cancer chemotherapy in a portable, comfortable, and effective way. Chemotherapy induced hair loss is a rapidly growing €8 billion global market with multiple established public companies in the industry. We’re seeking to recruit talented individuals with the ambition to drive the development of a new and innovative approach and join the management team at our Galway office.

The Role – Director of Quality Assurance and Regulatory Affairs

The Director of Quality Assurance and Regulatory Affairs will own and shape the Regulatory and Quality System functions at Luminate Medical. The appointee will be the main point of contact for regulatory authorities and notified bodies for the market introduction in 2024 of a Class II wearable medical device, alongside a future pipeline of high-impact, patient-facing products for people undergoing cancer treatment. We’re offering applicants the chance to join one of Ireland’s most valuable and well-funded growth-stage companies as a key early employee in a valuable leadership position. You will form part of the senior leadership group steering the growth of the company and its culture.

Working at Luminate Medical

• This is a leadership role at a rapidly growing and award winning MedTech company. You will have an opportunity to own and develop the Regulatory and Quality functions of a high-impact patient-facing product portfolio.
• We offer a highly competitive remuneration package commensurate with experience (available on application).
• We believe in quality of life in our product and for our people, offering a flexible benefit scheme, flexible working hours, and generous vacation policy. This position can have a significant work-from-home component.

What You Will Do:

• Develop, implement and maintain our Quality Management System (QMS). Train and oversee employees and collaborators in using the QMS.
• Develop regulatory approval strategies for Class II medical devices in both the US and Europe to ensure rapid translation of benchtop R&D to clinical implementation. Have hands-on ownership of regulatory submissions for clearance/approval.
• Train employees and other stakeholders on current and new regulatory requirements to ensure product compliance.
• Lead the team in identifying key regulatory and quality risks, identifying mitigation strategies, and reporting on these regularly to the wider team. Develop a risk register for internal risk management and for submission to regulatory authorities.
• Draft and lead ethics and regulatory approval documents for clinical studies.
• Negotiate with regulatory authorities throughout the product lifecycle.
• Provide input into overall company strategy as a member of the senior leadership team.

Personal Attributes – The Ideal Candidate Is:

• A proactive team player with exceptional leadership qualities.
• Resourceful, independent and self-motivated with a hands-on attitude.
• Able to complete honest self-evaluation of progress towards objectives. You can give and receive candid feedback in a constructive and positive manner.
• Willing to adopt, engage with and shape company culture in a positive manner.
• Outstanding in written and verbal communication and collaboration skills. You can confidently represent the company in external presentations and meetings with regulatory authorities.

Experience Requirements – The Ideal Candidate Must Have:

• Expert knowledge of ISO 13485, ISO 60601, ISO 14971, FDA Quality System Regulation, FDA 510k and De Novo Pathways, and EU MDR.
• Direct experience in leading the regulatory submission of medical device projects through FDA 510k clearance or De Novo approval. You have personally prepared and submitted materials to the FDA for clearance/approval of a medical device.
• Direct experience in interfacing with clinical teams in the approval of clinical studies. You have personally prepared and submitted materials for ethical approval of in-human clinical studies of a medical device.
• Direct experience of implementing a Quality Management System within a medical device development environment.
• Demonstrated people management skills, preferably within a MedTech environment. You are able to show examples of interfacing with R&D, Operations and Clinical teams to ensure regulatory and quality requirements are met.
• Understanding of product development and business strategy.

Experience Advantages – It Would be Advantageous to Have:

• Experience working with wearable devices which integrate mechanical and electronic components. You understand the challenges and regulatory requirements of garment design.