We are a rapidly growing medical technology company specialising in the design, development and manufacture of innovative medical devices. Due to continued growth, we have an exciting opportunity for a Senior RA Associate to join our highly motivated team.
The Senior Regulatory Affairs Associate will 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. Providing support to distributors and authorized representatives. 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.
Duties and Responsibilities:
* 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
If you are interested in finding out more about this opportunity or would like to apply, hit “Apply Now” or contract Harry Burt at Orion Electrotech Ltd
Medical Device Directive
Quality Management Systems