Regulatory Affairs Officer
To support the developing neurological activities at Renishaw, the position of Regulatory Affairs Officer has become available. This role requires an enthusiastic and self motivated individual, whose main role will be to assist the Regulatory Affairs team to meet stated objectives. In particular the individual in this role will assist in the preparation of regulatory submissions to many international markets, ensuring all products are in full compliance with the specific market regulations.
The key outputs and deliverables include the following:
- Assisting Product Development teams by providing regulatory input to each stage of the design process from concept through to product launch of new devices.
- Maintenance of already regulated products including investigating and implementation of regulatory requirements for new market territories identified.
- Assisting in the investigation of and reporting on problems as part of medical device vigilance reports
- The generation of regulatory submission documentation including technical files / design dossiers / 510(k)’s / PMA 's (Pre Market Applications)
Qualification and expertise:
All applicants must have the following:
- Educated to at least HND level in a scientific or a technical discipline
- Proven expertise in the MDD (Medical Device Directive) and AIMDD (Active Implantable Medical Device Directive)
- Proven expertise in liaising with regulatory authorities (including the FDA)
- Proven expertise in Class III medical devices
- Experience of preparing and reviewing clinical investigations for submissions including post market studies and data management
- Basic knowledge of ISO13485 and ISO14971 standards, and the FDA QSR (Quality System Regulation)
- Previous experience of conducting Risk Management activities
Although not essential, it is desirable if applicants have the below:
- A degree in a Technical Discipline
- Proven expertise in the regulation of implantable medical devices.
- Proven expertise in the involvement of clinical trials
- Proven expertise in medical devices incorporating software
Person specification:
The successful applicant will have the following characteristics:
- Excellent communication skills both written and oral
- Strong interpersonal and organisation skills
- Capable of influencing
- Initiative
Within a work environment, the individual will be able to demonstrate that they can:
- Work well under pressure
- Be accurate and provide good attention to detail
- Have the ability to record/interpret information to present back to design teams
- Have the ability to work well both on their own and as part of a team
- Work to deadlines
- Be able to demonstrate their proven practical skills
Location:
This role is based at the New Mills site at Wotton under Edge, Gloucestershire.
For any correspondence in relation to this role, please quote the reference no. NP4927. Thank you.
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