Position title: VP of Regulatory Affairs
Reports to: CEO
Position summary:
The VP of Regulatory Affairs is responsible for the quality and regulatory activities of the organization, including
the Quality Management System (QMS) and products in accordance with international standards,
best practice and customer requirements.
Relevant Knowledge and Skill requirements:
Establish and maintain an effective Quality Management System (QMS) in accordance with all applicable medical device regulations, including ISO 13485, US FDA Quality Systems Regulation (QSR), and Medical Devices Single Audit Programme (MDSAP). Lead Continuous Improvement of the Quality Management System. Input to regulatory aspects of technology & product opportunity evaluation. Lead quality and regulatory aspects within the product development process, e.g., standards.
Identification and interpretation, quality and regulatory resource, and activities planning. Work closely with internal and external multi-disciplinary product development teams to ensure project success. Plan and conduct internal audits and provide guidance regarding best practices and continuous improvement. Lead supplier management process, including Quality agreements, auditing, etc. Promote audit readiness and lead facilitation of audits of Leo Cancer Care and partner facilities by external regulatory authorities. Lead engagement with global regulatory authorities regarding the QMS and product Certification. Contribute to the development and achievement of Quality Objectives and Key Performance Indicators, reporting to the senior management team during Quality Management Review Meetings
Compile and maintain product documentation for initial and ongoing certification. Oversight of post-market activities e.g., surveillance, vigilance, customer feedback, failure analysis. Significant contribution to strategic planning and implementation of Regulatory and Quality Aspects of the business. Maintain a current expert knowledge of US FDA, EU MDR, and other applicable regulations, Legislations, best practices, and guidelines related to QA/RA, monitor changes to applicable laws and regulations, identify impact to the business, and, in collaboration with other stakeholders, develop response strategies and/or a work plan and complete according to the deadline.
Be responsible for training on the QMS for existing and new staff, and external parties. Management of the customer feedback/complaints systems and processes. Supporting and approving CAPAs, root cause analysis, and non-conformance investigation activities, validation activities, risk management, and design review. Support the senior management team in understanding the QA/RA framework in which the business is expected to operate.
Promote a high level of Quality both within the business and with external providers. Participate in the company’s Health & Safety activities and support compliance. Line management of the Quality Assurance and Regulatory Affairs team
Any other duties to support the company's business activities as required.
Key responsibilities
- Managing an ISO 13485 Quality Management System (QMS) under the Medical DevicesDirective (MDD)/Medical Devices Regulation (MDR) for product development and/or manufacturing in the UK/EU is essential.
- Management Representative and Person Responsible for Regulatory Compliance
- Knowledge of US FDA 21 CFR 820 Quality Systems Regulation is essential, and experience is highly desirable.
- Knowledge and experience of the medical device EU MDR conformity assessment process to obtain CE mark is essential.
- Knowledge of the US FDA product approval process e.g. 510k is essential and experience is highly desirable.
- Knowledge of other global quality & regulatory obligations is desirable. Experience of Class I and II devices is essential.
- Working with external contract design and manufacturing organizations is essential.
- Strong interpersonal and negotiation skills.
- Excellent attention to detail is essential.
- A strong team player who is motivated by the success of the business.
- A self-starter committed to making things happen.
- Able to work independently and lead relevant aspects of the QA/RA function.
- Experience of managing people.
- Ability to travel independently to venues around the UK and US at times and for durations required by the role. This may require the post holder to be away from the main base of operations for overnight periods and will also include international travel.
About Leo Cancer Care
Cancer is one of the biggest killers that we face today with 1 in 5 people diagnosed at some point in their life, it is something that affects us all. 50% of all patients diagnosed with cancer should receive Radiation Therapy as part of their treatment but due to the cost, size and complexity of current technology, the number that do is around half of that.
Current Radiation Therapy is delivered with a patient lying supine on a table while a large machine is rotated around them delivering radiation from different angles to kill the tumour. Lying on a table, many patients report that they feel like a passenger in their treatment feeling vulnerable through the entire process. Leo Cancer Care was founded with one clear goal, to bring a more human way to treat cancer and empower patients to face treatment on their feet.
We are looking for an enthusiastic individual to complement our passionate team in their mission to revolutionizing cancer treatment. You can be part of a world class team, developing the treatments of tomorrow.
Leo Cancer Care is helping make changes in Radiation Therapy by shifting to upright patient positioning, imaging and treatment. We do what we do to find a better way, a better way to treat cancer and create a paradigm shift in radiation therapy to benefit all. We will do this by improving the accessibility and quality of medicine in cancer care globally, making cancer treatment a more human experience for all.
Ways of Working
Leo Cancer Care is dedicated to fostering a diverse and inclusive workplace environment. We embrace and celebrate the unique backgrounds, experiences, and perspectives of all individuals. We believe that diversity enriches our organization and strengthens our ability to innovate and excel. Discrimination or harassment of any kind will not be tolerated. We encourage all qualified candidates to apply and join us in our mission to create a respectful and equitable workplace for all.
Leo Cancer Care is an equal opportunity employer.
