Regulatory Affairs Officer, Medical Devices
Medical devices regulatory affairs derby EU UK MHRA
My client is leading the development of technological and scientific solutions for the diagnostic and life science industry and specialises in instrumentation, software and sample preparation products and services for in vitro diagnostics (IVD). My client is looking to currently fill the position of Regulatory Affairs, Medical Devices. If you have substantial experience in this field and are looking to progress your career further then this could be the right move for you!
- Develops and implements regulatory strategy across projects to ensure that company products are safe, legal and meet or exceed customer expectations for compliance with national/regional/global regulations
- Maintain local process to ensure compliance with required regulatory standards and governing bodies in close cooperation with the local Senior Quality Assistant.
- Monitor international laws and trends, asses and communicate requirements and support implementation strategies for earliest possible compliance to new regulations within the Corporate.
- Manage and conduct regulatory interactions with local and corporate customers and/or authorities requests/inquiries dealing with regulations and product compliance.
- Prepare regulatory documents for national and international registrations.
- Liaise and negotiate with regulatory authorities to achieve approvals and registrations, e.g. 27001
- Support the Corporate RA Team in all activities to harmonise and keep up to date regulatory guidelines and legislation
- 3+ years minimum Regulatory Affairs experience within medical device environment.
- Excellent oral, written, and interpersonal communication skills. A second language (e. g. German, French or Spanish) is preferred.
- Analytical and problem-solving skills
- Exceptional organizational and time management skills
- Ability to work independently and proactively to meet goals and deadlines
- Experience with 510K premarket submissions
- Ability for cross border collaboration in a Corporate Team accompanied by limited business travel
Ability for cooperation and frequent communication with local management and Head of Corporate QM & RA