The Regulatory Affairs Specialist manages product registrations across assigned geographic markets and provides regulatory support to Rayner’s UK manufacturing facility. The role works closely with colleagues across the business to support process improvements, product changes and the development of new ophthalmic medical devices.
This role can be performed fully remotely, with regular virtual collaboration across the Regulatory Affairs team and wider business. Occasional travel may be required for meetings, audits or other business needs.
What You'll Be Doing:
- * Manage regulatory registrations for assigned international markets, from initial planning through submission, approval and ongoing maintenance.
- Work with Regional Sales Managers and other colleagues to develop registration and product launch plans that support business priorities.
- Prepare, submit and update regulatory applications, responding to questions from regulatory authorities and addressing gaps in existing registrations.
- Maintain accurate and accessible regulatory records, including technical documentation, registration information, regulatory correspondence and routine reports.
- Monitor and interpret regulatory requirements, guidance and standards, assessing their impact on Rayner’s products and processes.
- Review product, document and process changes to determine whether regulatory submissions, notifications or other actions are required.
- Provide regulatory input to product development, risk management and continuous improvement activities, ensuring requirements are considered at the appropriate stage.
- Support the development and validation of equipment, systems and processes, working with internal teams and suppliers as required.
- Communicate with regulatory authorities and other external partners, and support regulatory inspections and Notified Body audits.
- Contribute to Regulatory Affairs departmental activities and undertake other reasonable responsibilities appropriate to the role.
What Experience & Skills You Will Need:Essential:
- At least three years’ experience in Regulatory Affairs, Quality Assurance or a related medical device role.
- A relevant scientific or engineering degree, or equivalent Regulatory Affairs experience.
- Practical knowledge of the EU MDR and ISO 13485.
- Experience of medical device registrations and technical documentation.
- Strong analytical, planning and communication skills, with the ability to work independently in a remote environment.
Desirable:
- Experience of international registrations and working with distributors.
- Knowledge of MDSAP and US FDA requirements.
- Experience of supporting audits or inspections.
- Registration experience in priority international markets.
- Familiarity with regulatory, document-management or ERP systems.
What We Can Offer You:
- * Comprehensive benefits package including Health and wellness allowance
- Employee Assistance Program
- Global appreciation platform to recognize colleagues around the globe
- Being part of an organization, you can be proud to work for changing the lives of millions of people!
