Regulatory Affairs Associate – Up to £38K
Our client is a company within the Medical Sector with a long-established culture of designing and manufacturing exceptionally high-quality innovative measurement and diagnostic instruments for the eye care industry.
They are looking for a Regulatory Affairs Associate to join their team and be responsible for maintenance of product registration worldwide, providing support to distributors and authorized representatives as well as new product registration and compilation of necessary documentation.
Working closely with the Quality System Manager and Senior Regulatory Affairs Officer the role holder will be involved in managing certain parts of the quality management system.
- Responsible for new regulatory submissions and renewal
- Providing regulatory support across the company and to external customers
- Overseeing complaint analysis, reporting complaint trends
- Responsible for post-market surveillance
- Maintaining current knowledge of relevant regulations and providing input into management review meetings
- Educated to degree level in a science or engineering subject (2:1)
- Hosting internal audits, liaising with Notified Body and arranging the audits of technical files
- Familiar with ISO 13485 and GMP requirements
- Ensuring full compliance with regulatory requirements in US, EU and other territories (advised by Sales)
- Experience with risk management techniques to ISO 14971
- Must be able to take initiative, motivate others, solve problems and deliver results independently as well as working within a multi-disciplinary team environment.
- Strong communication skills and ability to influence internal stakeholders and external customers and suppliers with strong analytical reasoning, and a demonstrable hand -on approach to work.
- Must be commercially aware with the ability to fully understand the contributions that small regulatory details can make to the larger business picture.
- Excellent communication and report writing skills.