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 which revolutionise the patient experience of healthcare and radically improve quality of life. Our first product is a wearable medical device to prevent the hair loss caused by cancer chemotherapy. Luminate’s Lily Device is a portable, comfortable, and more effective solution to preventing chemotherapy induced hair loss than the current standard.

 

Delivering this vision and product hinges on having a great Regulatory and Quality function. This means building regulatory strategies that efficiently bridge the gap between innovation and real patient impact. Implementing quality management processes that ensure an empowering experience for every patient. Driving regulatory clearance so that patients can finally have access to the products that solve the needs that matter to them.

 

We're looking for a Director of Regulatory Affairs to lead, grow, and shape our Regulatory and Quality functions as the company grows. You will be the primary author of a 510(k) submission to bring Luminate's Lily Device to market by the end of 2023. Beyond that, you will develop regulatory strategies and drive submissions for approval/clearance of pipeline products in the US and EU. You will implement a new Quality Management System and lead the implementation of Quality procedures across the business. You will work as part of the company's senior management team as a core business leader with a direct voice in the growth of one of Ireland's most valuable clinical stage companies.

 

This position requires a strategic mind who can contribute to the clinical, quality, regulatory and commercial strategy of the business. You have deep knowledge of FDA and EU MDR approval pathways. You are comfortable implementing a quality management system in a step-wise, efficient manner. You love working cross-functionally to make sure great innovation seamlessly transitions into great products making a real impact in the market.

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Working at Luminate Medical

• This is a leadership role. You will have an opportunity to own and develop the Regulatory and Quality functions of a high-impact patient-facing product portfolio with immediate patient impact (launch in 2023).

• We offer a highly competitive salary and stock compensation package comparable with multinational medical device companies (available on application).

• We offer a flexible working environment with significant annual leave and working hours flexibility. This position can be remote, hybrid, or in-office.

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What You Will Do:

• Provide input into overall company strategy as a member of the senior leadership team, and grow and develop the Regulatory and Quality functions.

• Author a 510(k) application for clearance to be submitted in December 2023. Develop regulatory approval strategies for pipeline 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.

• Develop, implement and maintain our Quality Management System (QMS). Train and oversee employees and collaborators in using the QMS.

• Negotiate with regulatory authorities throughout the product lifecycle.

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Personal Attributes – The Ideal Candidate Is:

• A strategic leader who can help shape overall company strategy.

• A proactive team player with exceptional leadership qualities.

• Resourceful, independent and self-motivated with a hands-on attitude.

• Outstanding in written and verbal communication and collaboration skills. You can confidently represent the company in external presentations and meetings with regulatory authoritie

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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 of implementing/overseeing a Quality Management System within a medical device environment.

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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.

• Understanding of clinical trial strategy, product development processes and business strategy.