Regulatory Compliance Specialist (EU MDR)

at  Currentbody

ABOUT US:

We are CurrentBody, The Beauty Tech Experts. We are the global leaders in beauty tech, bringing the latest and most effective beauty products to customers across the globe.
We are pioneers of one of the most talked about beauty products in recent years, our anti-ageing CurrentBody Skin LED mask and we are making luxury beauty devices accessible to millions. With over 20 international ecommerce sites, we are strategic partners of some of the most exciting and innovative beauty companies too.
As we continue to disrupt the beauty market with innovations, category expansion and expert service, we are building a team to drive our growth over the coming years from our Headquarters in Cheshire, England.

CANDIDATE REQUIREMENTS:

• Experience in regulatory compliance, specifically with EU MDR.
• Strong knowledge and experience of EU MDR is essential
• Strong attention to detail, organisational skills, and ability to work in cross-functional teams.
• Bachelor’s degree in Life Sciences, Law, Regulatory Affairs, Cosmetic Science, or a related field.

The Regulatory Compliance Specialist – EU MDR will focus on ensuring compliance of our beauty tech devices with European Union Medical Device Regulation (EU MDR). The successful candidate will play a critical role in ensuring that our medical devices comply with the EU MDR requirements, maintaining regulatory approvals, and supporting the company’s regulatory strategy in the EU.

• Interpret and apply the requirements of EU MDR to ensure ongoing compliance for existing and new medical devices.
• Manage Technical Documentation in compliance with EU MDR, including Clinical Evaluation Reports (CERs), Risk Management, and Post-Market Surveillance (PMS) plans and reports.
• Stay updated on regulatory changes, guidance, and best practices, communicating updates to relevant teams.
• Ensure device labelling, Instructions for Use (IFU), and Unique Device Identification (UDI) processes align with EU MDR requirements.
• Collaborate with internal teams to implement and maintain UDI submissions in EUDAMED.
• Prepare and submit regulatory files to Notified Bodies (NBs), including initial CE marking applications, renewals, and changes.
• Act as the primary point of contact with Notified Bodies and Competent Authorities to address queries and facilitate audits.
• Work closely with R&D and the regulatory team to ensure compliance with EU MDR throughout product development.