Senior Regulatory Affairs Officer

Technical/Professional            ·            Charfield, UK           ·            Full time

Locations: Charfield, UK

Time type: Full time

Job requisition id: R4371

Job Description

A vacancy has arisen for an experienced Regulatory Affairs Officer. Working within Renishaw Neurological Solutions the successful candidate will be required to provide regulatory support across the full lifecycle of the products. This will include supporting the design, development, manufacture and post market surveillance of a range of medical devices including Drug delivery and Robotic products. Key tasks will include the provision of regulatory advice to project teams leading to the generation of technical files and design dossiers in support of CE marking, UKCA Marking and US approvals.

Working closely with the development team they will relay regulatory requirements in a clear and understandable way throughout the development process. Support for current products is also required to ensure Renishaw maintains compliance with EU and UK regulatory requirements. On occasion, this will involve delivery of awareness training of relevant regulatory requirements to other team members. The role will also provide support to and may deputise for the Regulatory Affairs Manager as required.

Responsibilities

• Give advice on regulatory issues to the development teams
• Research and write submissions for Pre-Market Approval
• Provide regulatory support for clinical studies
• Input into PMS activities
• Support the Risk Management process
• Creation, implementation and maintenance of Regulatory procedures

Key requirements

• Working knowledge of MDR and CE marking process
• Experience in 510(k) or PMA submissions
• 5-10 years’ experience in a medical device Regulatory position
• life science, engineering or medically-related degree.
• Working knowledge of EU, US and other Regulatory Pre-Market Submissions
• Experience in ISO 13485, ISO 60601, ISO62304 and ISO 14971
• Experience in 21CFR Part 820 Quality System Regulation (QSR)
• Excellent communication skills

Desirable requirements

• Experience of working with clinical trial applications
• Experience in drug delivery devices or robotic and software products
• Experience in MDSAP
• Knowledge of product development documentation for Medical Devices
• Knowledge of ISO 62366, and ISO 14155
• Expertise in Design Control to 13485/21CFR part 820
• Familiarity in dealing with notified body visits

Benefits 

When you join Renishaw, we’re committing to your future career. That’s because we believe in developing our people’s skills and promoting them internally. We also offer a benefits package that’s highly desirable; including a 9% non-contributory pension, discretionary annual bonus, *subsidised onsite restaurants and *coffee shops, free parking, *car sharing scheme and *24 hour fitness centres. (*not available at our Castle Donington, Exeter, York & Edinburgh sites)

We also want to promote a healthy work-life balance as much as possible, so we have introduced a Homeworking policy which allows for a combination of home and office based working depending on the nature of your role. We also offer a variable working programme, 25 days holiday plus bank holidays, Life Assurance Policy of 4 times annual salary, Cycle to Work scheme, enhanced maternity pay subject to qualifying criteria, the option to join BUPA Renishaw health trust and an Employee Assistance Programme for employees and family.

Please click here for further information about our benefits.

Employment Type: Permanent

Time Type: Full time

Requisition Number: R4371 Senior Regulatory Affairs Officer (Open)

Please click here to apply.