Shape the Face of Cancer Treatment at Luminate Medical

Luminate Medical is on a mission to change the way we experience cancer care. We design and build products that eliminate the side effects of cancer treatment in a comfortable, portable and effective way. We’re currently building our flagship product Lily, a wearable medical device to prevent the hair loss caused by chemotherapy, and Lilac, our next-in-portfolio product to prevent peripheral nerve damage in chemotherapy patients.

 

We’re looking for a Director of Quality and Regulatory Affairs to become the next key person in our leadership team. You will own and shape the Quality, Regulatory and Design Assurance functions at Luminate Medical, overseeing the implementation of an ISO13485-compliant Quality System, supporting R&D colleagues in the design of design verification and product inspection programs, and supporting the development of submissions for market approval in the US and Europe. You will be a part of the leadership team introducing a suite of quality-of-life oriented medical devices for cancer patients, playing a key role in driving innovations from benchtop to patient bedside.

 

This position requires an experienced leader who wants to bring impactful new products to market and shape the organisation’s culture. The ideal candidate will be a keen problem-solver and eager to work alongside R&D colleagues in early-stage product development alongside an interest in supporting clinical affairs. Above all, you will need clear attention to detail, enjoy working in a fast-paced environment, and thrive in taking responsibility for ensuring that patient needs are met with a quality product.

​

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 Design Assurance and Quality functions of a high-impact patient-facing product portfolio. You will also play a key role in Regulatory affairs, though experience here is an advantage, not a requirement.

• We offer a highly competitive salary comparable with multinational medical device companies (available on application), a flexible benefits package, alongside a company laptop, headphones, camera and teamwear.

• We believe in quality of life in our products and for our people, offering flexible working hours and a generous vacation policy.

​

What You Will Do:

• Oversee next phase development of our Quality Management System (QMS) and achieve ISO13485 certification. Oversee creation of ISO13485-compliant production environment.

• Train employees and other stakeholders on current and new regulatory requirements to ensure product compliance.

• Lead the design assurance strategy through all phases of product development and into marketing submissions, including design reviews, and design verification and validation strategy.

• Support clinical trial regulatory and ethics submissions, quality control documentation, and data capture system design.

• Ensure clinical trial programs sponsored by Luminate Medical are GCP compliant.

• 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. Play a key role in submissions for regulatory clearance to market.

• Negotiate with regulatory authorities throughout the product lifecycle and become the key point of contact with regulatory authorities for audits.

• Provide input into overall company strategy as a member of the senior leadership team.

​

Personal Attributes – The Ideal Candidate Is:

• Creative: A creative problem solver who is enthusiastic about new ideas and bringing new products to market.

• Open: A proactive team player who is willing to adopt, engage with and shape company culture.

• Communicative: Outstanding in written and verbal communication and collaboration skills. You can confidently represent the company in external communications.

• Self-Driven: You have a sense of urgency in your work, are resourceful and independent, and thrive when taking responsibility for tasks.

• Accountable: You can prioritise your list of tasks independently and ensure actions are completed on time.

​

Experience Requirements – The Ideal Candidate Must Have:

• Expert knowledge of ISO 13485, ISO 60601, ISO 14971 and awareness of technical file requirements as per US and EU regulations.

• Direct experience of implementing a Quality Management System within a medical device development environment.

• Prior experience in completing Design Assurance activities for early stage medical devices resulting in successful design reviews and product launches.

• Direct experience in interfacing with clinical teams in the approval of clinical studies. You have personally prepared and submitted materials for ethical and regulatory approval of in-human clinical studies of a medical device.

• 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.

• 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.