We’re looking for a highly experienced, driven, Head of Regulatory. You will have a passion for detail and excellence, to help us execute world-class manufacturing and help us to bring the next generation of minimal access, surgical-assist robot to market.
If you’re a motivating leader, who enjoys driving a team to achieve high priority objectives and goals, this could be the right opportunity for you! You’ll need to be a forward thinker who will thrive in a fast paced, developing and ever-changing high-tech environment. Your collaborative nature and pragmatic and logical approach will enable you to confidently work with a range of stakeholders across the global business, to ensure successful outcomes are achieved, and innovations embraced.
Reporting to the Operations Director, 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.
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 breathtaking 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.
Every day will be different but some of your main responsibilities will be:
- Working with the relevant business divisions 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:
- Experience the medical device industry with specific experience of the requirements of MDD/MDR; US FDA
- Good working knowledge of risk management (ISO 14971), and GMP/ISO 13485
- Strong collaboration and negotiation skills
- Good experience of mentoring and developing teams, having successfully led small teams in the past
- Strong attention to detail and the ability to multi-task and balance competing priorities
- The ability to build relationships between the Regulatory team and other areas of the organisation and to communicate effectively at all levels
- A demonstrable hands-on approach to regulatory affairs, not being afraid to get involved with real issues
- A responsive approach with the ability to differentiate and prioritise between multiple conflicting priorities without losing sight of long-term strategic goals
- Excellent communication skills with a significant background in the day-to-day running of a manufacturing quality function
- An innovative approach to problem solving
- A detailed understanding of what it takes to ensure regulatory compliance in a manufacturing and medical devices business
In terms of education, we’d like you to have a degree or higher in a relevant life science, scientific or engineering-based discipline, but a combination of education and experience may be considered. Being computer literate is essential; good written & verbal English also necessary. You’ll also need to be able to travel occasionally when required.
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.