Regulatory Affairs Specialist
2 months ago
Cure Talent is delighted to be partnered with a global Medical Device company, specialising in emergency medical products, who due to their exceptional continued growth, have an exciting opportunity for Regulatory Affairs Specialist to join them on an initial 6-month Fixed Term Contract.
This is a fully remote position and can be based anywhere in the United Kingdom or European Union.
As their new Regulatory Affairs Specialist, you will play a pivotal role in Product Registrations across the EU and Rest of the World, contributing to the global regulatory strategy for a portfolio of life-saving products.
To be successful as their new Regulatory Affairs Specialist, you will have proven Regulatory Affairs experience in the Medical Device sector with a variety of classes of Medical Device and extensive experience in EU & RoW Medical Device Product Registrations.
Key Responsibilities
- Work with internal teams and external regulators to ensure ongoing product compliance with applicable standards and regulations.
- Register medical devices in new international markets and maintain existing registrations.
- Assist in the review and maintenance of technical product files, including the ongoing MDR transition.
- Collaborate with design engineers to produce essential technical documentation, such as risk assessments and test reports.
- Provide regulatory documentation support to the Sales team for market registrations.
- Partner with authorities, Notified Bodies, and other national regulators on company and product registrations.
- Support regulatory requirements for CAPAs, NCRs, and customer complaints.
Experience and Skills Required
- Proven Regulatory Affairs experience within the Medical Device sector
- Extensive experience with global product registrations for the UK, EU and Rest of World
- Knowledge of medical device standards, including ISO 13485, and familiarity with Medical Device Regulations.
- Experience of a variety of classes of Medical Devices, preferably Class IIa & IIb
If you have the skills and experience needed to be successful in this role, please get in touch with Kris Holmes today
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