Regulatory Affairs Associate – £32-38K
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 preparing and maintaining registration packages in line with global international regulatory requirements and guidelines. The role holder will be providing support to distributors and authorized representatives as well as new product registration and compilation of necessary documentation, as well as maintenance and collation of Technical Files (compliance to MDR).
This is a pivotal role working closely with the Regulatory Affairs Team. He/ She will also work closely with the Quality Team and 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 and maintenance of clinical evaluations.
- Maintaining current knowledge of relevant regulations and providing input into management review meetings
- Reviewing and approving processes, product changes, labelling changes to identify regulatory impact
- Lead and execute transition of MDD Technical Files to MDR Technical Files
- Creation and maintenance of Essential Requirement Checklists, Technical Files, and Declaration of Conformity for CE Marking
- Participation in External Audits performed by external Authorities such as Notified Body Audits
- Educated to degree level in a science or engineering subject (2:1)
- Experience with and well understanding of Medical Device Directive 93/42/EEC and Medical Device Regulation (EU) MDR 2017/745
- Sound knowledge of CE marking of Medical Devices as per the requirements set out in the Medical Devices Directive 93/42/EEC and Medical Device Regulation (EU) MDR 2017/745.
- Experience and sound knowledge of Medical Device Symbols and Labelling requirements as per BS EN ISO 15223
- Liaising with Notified Body and arranging Technical Files Audits
- 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.