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!