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Ready to make a global impact? Join our Regulatory Affairs & Quality Assurance team to ensure 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. Your responsibilities include: Managing product labelling and artwork Assessing medical device complaints Handling customer complaints involving National Authorities Maintaining our Quality Management System (ISO 13485) Ensuring continuous improvement You'll also be responsible for: Regulatory intelligence and monitoring changes in medical device legislation Global product registrations and renewals Reviewing legislation changes and maintaining our medical device legislation trackers Updating our approved suppliers list in collaboration with the Compliance Manager Your expertise will be crucial in advising on legislative changes, speaking with notified bodies and competent authorities, 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 excel in this role, you'll need: Previous global medical device and regulatory experience A solid understanding and application of global medical device legislation and conformity processes for Class I medical devices Experience with ISO 13485 Quality Management systems and procedures This role closes on 16th January 2025; however, we may close the advert sooner if we receive a high volume of quality applications. Don't delay your application; apply now!
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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. Your responsibilities include: Managing product labelling and artwork Assessing medical device complaints Handling customer complaints involving National Authorities Maintaining our Quality Management System (ISO 13485) Ensuring continuous improvement You'll also be responsible for: Regulatory intelligence and monitoring changes in medical device legislation Global product registrations and renewals Reviewing legislation changes and maintaining our medical device legislation trackers Updating our approved suppliers list in collaboration with the Compliance Manager Your expertise will be crucial in advising on legislative changes, speaking with notified bodies and competent authorities, 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 excel in this role, you'll need: Previous global medical device and regulatory experience A solid understanding and application of global medical device legislation and conformity processes for Class I medical devices Experience with ISO 13485 Quality Management systems and procedures This role closes on 16th January 2025; however, we may close the advert sooner if we receive a high volume of quality applications. Don't delay your application; apply now!
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