We’re looking for a highly experienced, driven, Head of Regulatory Affairs. You will have a passion for detail and excellence, to help us execute world-class manufacturing and to bring the next generation of minimal access, surgical assist robot to market.
Why join us?
CMR is one of the UK’s most exciting companies to be joining right now. The scale of our ambition to build a world-class medical devices company in Cambridge is matched only by the breath-taking innovation that underpins our next generation of surgical robot. We’re an award-winning company that plans to significantly disrupt the way surgery is performed for the benefit of millions of patients all around the world.
Our values are ambitious, humble, people focused and fair and responsible. If you share these values, our passion for improving lives, and have the skills to make a real difference to the way minimal access surgery is developed and delivered, then it’s a great time to join us.
Reporting to the Chief Quality Assurance & Regulatory Affairs Officer, you will provide vision, leadership, support, collaboration and direction that ensures our systems and instruments are delivered to the highest standard. You will take a hands-on approach to leading the Regulatory function, working closely with the quality and manufacturing teams, and will have the skills to:
- Implement the Regulatory strategy to achieve strategic operational goals
- Guarantee the continual compliance of regulatory standards for products and processes to ensure reliability, consistency and safety
- Monitor and report Key Performance Indicators across all areas of the regulatory function
- Collaborate with other teams and functions across the business to drive best practise in the approach to regulatory
Through providing direction as part of CMR’s regulatory function, you’ll be able to have a real impact on the success of the business.
Every day will be different but some of your main responsibilities will be:
- Working with the relevant business functions to identify regulatory requirements for Versius
- Collaborating with all teams across the business to ensure all product meets the applicable regulatory requirements
- Representing CMR in regulatory matters to influence outcomes and establish strong and valuable partnerships including communicating with regulatory and governmental agencies
- Overseeing the process of preparing product submissions to domestic and international regulatory bodies and leading the process from inception to approval
- Close collaboration with the Clinical team to ensure that patient safety is always maintained
- Leading and guiding the team to deal with complex negotiations with regional regulatory authorities
- Advising the business of any Regulatory changes/new requirements affecting CMR Surgical, and medical devices, assessing their impact on the business and implementing changes where necessary
- Leading and supporting the team in the writing and editing of technical documents
- Leading research, analysis and communication of information pertaining to the appropriate regulatory pathway for new or modified products
- Managing post market surveillance activities, complaints, field safety corrective actions, product recalls and medical device reporting of adverse incidents and evaluate to determine any regulatory actions required
We’re a high growth company and as such roles change and evolve. We’d expect you to be willing to turn your hand to anything within the Regulatory remit that helps the team deliver its objectives.
You’ll have a thorough and sound working knowledge of regulatory compliance in Europe, USA, China and Japan, and a track record of successfully gaining regulatory approvals in various markets. We would also like you to have:
- Substantial senior medical device regulatory experience in multinational OR: Director-level experience for QARA in a smaller medical device company
- Leadership & management experience at senior level: coaching/mentoring/growing/shrinking teams; managing upwards & horizontally
- US FDA & CE marking experience for complex medical devices
- Post market surveillance experience in at least US or CE market for complex device
- Be an expert in medical device standards and regulations applicable in US and CE
In addition, you must have at least 2 of the following
- International regulatory experience (China, South Korea, Japan, Brazil)
- Sterile product experience
- Complex electro-mechanical experience, ideally Class III devices
- Software-heavy device experience
- Proven track record of driving up regulatory awareness within company through design, development, manufacturing
- MBA or similar qualification
We offer a competitive salary and a great benefits package (including non-contributory pension scheme, cycle-to-work scheme, life assurance, and our legendary monthly BBQs). On top of that, you’ll be joining a company with a fabulous culture of ambition, creativity and teamwork, and where fun is just as valued as our commitment to make surgery better for millions of people.