Software Quality and Regulatory Specialist
Cambridge, Cambridgeshire, England
Software Quality and Regulatory Specialist - CMR SURGICAL
Why join us?
CMR is one of the UKs 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. Were 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 its a great time to join us.
We're looking for an experienced medical device engineer with a passion for software quality and who can coordinate the worlds of software engineering and medical device regulatory and quality management. You can enable a great team get on with developing our surgery-transforming robot while maintaining the highest standards of safety and regulatory compliance.
You'd work at a senior level within the software team to:
assist with the preparation of the software aspects of technical files,
drive improvements in processes for software development, documentation, release and maintenance,
help maintain compliance with regulation within software development, coordinating with the quality and regulatory affairs team,
develop and deliver internal process training to engineering teams, and
- oversee our requirements management tool and traceability of design documentation.
Were a high growth company and as such roles change and evolve. Wed expect you to be willing to turn your hand to anything within the remit that helps the company deliver its objectives.
This is not primarily a software-writing role, but being able to roll up your sleeves and write scripts occasionally would be an advantage.
Youll have a 2.1 or above in engineering, science or other relevant discipline, and at least 5 years experience in the medical device industry (including consulting if relevant).
Required Skills and Experience
- Demonstrated insight, understanding, and experience of applying relevant international standards not just working under them:
IEC 62304 and IEC 60601,
ISO 14971 and an understanding of different tools for software risk management,
FDA guidance on software in medical devices
An understanding of the product lifecycle and especially medical device software.
- Excellent technical communication skills, able to write and speak to different audiences in appropriate language.
You will have a passion for delivering safe, effective, high quality devices for the benefit of patients. To that end, youll be able to articulate the importance of quality process in language that engineers can understand, but also to help evolve that process in a way that aligns with company quality objectives and regulatory requirements.
Desirable Skills and Experience
Experience with requirements management systems (eg. IBM DOORS or similar)
Involvement with writing or managing regulatory submissions (eg FDA 510(k), MDD CE mark)
Experience setting up software process, coding standards, QA teams, etc., especially in a medical device context
Python programming skills (eg. for scripting reporting operations)
Experience with manufacturing software development and validation
Training and experience as an ISO 13485 and/or ISO 27001 internal auditor
- Understanding of device cybersecurity issues and risk management
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, youll be joining a company with a culture of ambition, creativity and teamwork, with a commitment to make surgery better for millions of people.
Interested? Wed love to hear from you!
Posted 17 days ago