Regulatory Affairs Manager

Ready to make a global impact? Join our Regulatory Affairs & Quality Assurance team to make sure that our products are safe, compliant and perform as intended across all markets. 

As a Regulatory Affairs Manager, you’ll support the Global Head of Regulatory Affairs & Quality Assurance in staying ahead of legislative changes and ensuring compliance. You’ll be the go-to person for keeping our technical files up to date and ensuring our medical device products meet global legislation. You’ll manage product labelling and artwork, assess medical device complaints and handle customer complaints involving National Authorities. Your keen eye for detail will help us maintain our Quality Management System (ISO 13485) and ensure continuous improvement. 

You’ll also be responsible for regulatory intelligence, monitoring changes in medical device legislation and alerting stakeholders proactively. Your role will involve global product registrations and renewals, reviewing legislation changes and maintaining our medical device legislation trackers. You’ll work closely with the Compliance Manager to update our approved suppliers list and make sure new suppliers meet our due diligence requirements. 

Your expertise will be crucial in advising on legislative changes, speaking with notified bodies and competent authorises, conducting internal audits and managing product labelling and packaging requirements. You’ll also handle Health Hazard Evaluation Assessment, maintain the artwork master list and oversee our new materials evaluation process. 

To be the best in this role, you’ll need previous global medical device and regulatory experience. Have a solid understanding and application of global medical device legislation and conformity processes for Class I medical devices. Additionally, you’ll need ISO 13485 Quality Management systems and procedures experience.