Vision RT Ltd

Compliance

• Position sits within the Quality and Regulatory team and reports to the Regulatory Affairs Manager.
• Play a pivotal role in obtaining and maintaining marketing approvals for Vision RT products globally.
• Lead product submissions to competent authorities in line with the company’s product development roadmap and market expansion strategy (focus on EU and US, including RoW).
• Act as extended member of R&D to develop and implement regulatory plans for new and changed products.
• Monitor and analyse changes in the regulatory environment and implement strategies to meet new requirements.
• Liaise with internal and external stakeholders, provide training and support to ensure regulatory requirements are met.
• Prepare and submit pre- and post-market reports to regulators and local representatives.
• Maintain Technical Documentation to document compliance with applicable standards, regulations and guidance.
• Act as an auditor of internal functions and external suppliers.
• Occasional UK and international travel.

Regulatory Affairs Specialist – Medical Devices