Supplier Quality Engineer
Exactech
Regulatory Affairs Specialist – Medical Devices
Vision RT Ltd
full-time
Posted on:
Origin: • 🇬🇧 United Kingdom
Visit company websiteJob Level
Mid-LevelSenior
About the role
- 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.
Requirements
- Regulatory Affairs experience in a medical device company.
- ISO 13485 or MDSAP
- Experience of CE marking (MDR) medical devices and/or preparing US 510(k) (FDA) submissions.
- Competent in Microsoft Word, Excel, PowerPoint, Outlook and general computer usage.
- Fluent in written and spoken English.
- A degree/qualification in health sciences, medical engineering, law or similar field.
- Experience of internal and/or supplier audits to ISO 13485, MDSAP and/or ISO 9001.
