Senior Regulatory Affairs Associate – Up to £45K
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 Senior Regulatory Affairs Associate to be responsible for the maintenance and creation of technical files, provide regulatory advice, support and expertise by developing regulatory strategies, preparing and maintaining registration packages in line with global international regulatory requirements and guidelines, and providing support to distributors and authorized representatives.
This is a pivotal role working closely with the Regulatory Affairs Team. The role holder will also work closely with the Quality Team and be involved in managing certain parts of the quality management system.
- Preparation of Regulatory dossiers for registration submissions to Health Authorities (globally)
- Providing regulatory support across the business and to external customers such as Distributors and Third-Party Manufacturers
- 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
- Experience in assessing and providing input to the Risk Management processes as per the Risk Management for Medical Devices – ISO 14971
- Experience in reviewing and creating Clinical Evaluations for Medical Devices
- Participation in cross-functional product development teams as the
- regulatory representative; development of regulatory strategies
- Assess changes in regulations and determine regulatory impact
- Reviewing and approving processes, product changes, labelling changes to identify regulatory impact
- Experience in reviewing Promotional and Non-Promotional Marketing Materials
- Overseeing complaint analysis, reporting complaint trends
- Responsible for Post-Market Surveillance (PMS)
- Maintaining current knowledge of relevant regulations and providing input into management review meetings
- Planning and executing internal audits
- Participation in External Audits performed by external Authorities such as Notified Body Audits
- To be successful in this role you will have a life science degree (pharmacy/ chemistry/ biology) with a minimum of 3+ years’ experience in Regulatory Affairs from within a Medical Devices regulated environment.
- 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 knowledge in Software as a Medical Device (SaMD).
- A good understanding and experience of Design Control, Device Life Cycle, Risk Management, Verification and Validation processes.
- Experience with Risk Management techniques in order to comply to Risk Management for Medical Devices – ISO 14971
- Experience and sound knowledge of Medical Device Symbols and Labelling requirements as per BS EN ISO 15223
- Substantial experience in the Medical Device Manufacturing and Healthcare industry
- Hosting and Planning internal Audits
- Liaising with Notified Body and arranging Technical Files Audits
- Experienced Auditor of Quality Management Systems for ISO 13485 and FDA 21CFR part 820
- Experienced in Global Medical Device Registrations/ Approval process
- 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 a hands -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.
- Must be a team player and capable to participate with commitment and sense of ownership.