We’re looking for an experienced Medical Safety Officer (MSO) to provide medical safety input during the development and life-cycle management for the growing pipeline at Cambridge Medical Robotics.
In this role, as a key member of a multi-disciplinary, world-class product development team, your responsibilities will include:
- Assess product benefit-risk and provide medical input and review to risk management reports, Product Issue Assessment/ Health Hazards Evaluations, Clinical Evaluation Reports and Product Safety Surveillance Plans.
- Conduct clinical interpretation of; post-marketing safety data, complaint data and safety reports, literature reports, and input into design and interpretation of safety endpoints in clinical studies.
- Provide medical safety input throughout product development and life-cycle management; such as FMEA and design reviews, customer training materials and manufacturing and design issues.
- Provide medical safety expertise, oversight and guidance; by interfacing with customers/users to gather additional medical data to support investigations, in Quality Review Board decisions and overall safety evaluations of products, review appropriate reports and filings and review responses to regulatory bodies, clinicians and patients when safety issues are involved.
- Monitor external sources/trends and identify and escalate emerging issues. These may include; complaint & medical device reports and vigilance trends, regulatory & market trends and intelligence, literature and scientific publications, review of adverse events and complaints
You’ll need to be medically qualified (MBChB, MBBS, MD or equivalent degree), with the ability to work effectively in a cross-functional team, and ideally have some, or all of the following:
- Minimum of 3 years’ clinical experience (may include academia, medical training, etc.), ideally with relevant surgical experience
- Experience in medical device development and regulations
- Knowledge of basic statistical techniques and epidemiological principles
- Experience in risk evaluation and mitigations
- Highly logical thinker
- An assertive and effective communicator, reporting at all levels
- A confident team member, with the ability to deal with people and situations at all levels
Obviously, we’re asking for a lot in the above. In return we offer a competitive salary and a great benefits package (including contributory pension scheme, life assurance, private medical insurance, childcare vouchers, cycle-to-work scheme and our now famous monthly company 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.
Why join us?
Cambridge Medical Robotics is developing a next-generation robotic system for universal keyhole surgery. The Versius system comprises a surgeon console, modular light-weight robotic arms and a range of wristed 5 mm instruments. The system uses state-of-the-art 3D high-definition imagery, significantly enhanced flexibility, and incorporates haptic feedback to provide surgeons with life-like sensitivity. In short, we’re creating something truly amazing designed to improve the lives of people around the globe; it’s a vision that excites us and hopefully will excite you.
Versius overcomes obstacles to widespread adoption of robotic minimal access surgery, namely robot size, instrument size, versatility, port placement, cost and ease of use, allowing the system to be highly utilised and ultimately cost-comparable to manual laparoscopic surgery.
The Company was formed in 2014 and has its headquarters in Cambridge, United Kingdom. We’re privately owned and enjoy strong financial backing.