Senior Regulatory Affairs Specialist

. An exciting opportunity awaits to play a key role in new product development and product changes. You will work closely with R&D and cross-functional teams. Together, you will ensure our medical devices meet global regulatory requirements.

You'll act as a trusted expert. You will combine your knowledge of EU MDR, MDD, CE Marking, and international regulations for medical devices. This will help guide products from development through commercialization and lifecycle management.

The role

• Lead Regulatory Affairs activities throughout the process of developing products, partnering with R&D from concept through development, CE Marking and commercialization.
• Provide regulatory leadership for sustaining engineering and product change projects, assessing regulatory impact and defining strategies.
• Develop practical approaches to intricate regulatory issues and take a hands-on approach to driving projects through to completion.
• Prepare, review and approve technical documentation, ensuring adherence to the EU medical device regulations and directives as well as BD quality systems.
• Review product and process changes, labelling, claims, complaints and advertising and promotional materials to resolve regulatory requirements.
• Provide regulatory expertise to Clinical Evaluation Reports (CERs), Periodic Safety Update Reports (PSURs), risk management activities and quality system procedures.
• Assess changes to regulations and standards, resolving their impact on products and the wider business.
• Support MDD-to-MDR transitions, product registrations and regulatory authority or notified body audits where required.

• Extensive background in regulatory matters within the medical device industry, with a strong track record of managing sophisticated regulatory activities
• Experience handling medical devices classified as Class IIa and/or Class IIb under MDD and MDR regulations.
• Demonstrated ability to lead regulatory activities, influence cross-functional partners and provide solutions to sophisticated regulatory challenges.
• Proven capability to direct regulatory activities, engage cross-functional collaborators, and deliver solutions to complex regulatory challenges.
• Demonstrable experience supporting EU MDR compliance and CE Marking.
• Working knowledge of key medical device standards, including IEC/EN 60601-1, IEC/EN 60601-1-2, IEC 62304, IEC 62366, ISO 14971 and ISO 13485.
• Good knowledge of Design Control, software lifecycle, risk management and verification & validation processes.
• Capable of converting sophisticated regulatory requirements into practical solutions for cross-functional teams.
• A proactive, collaborative approach demonstrating a deep sense of ownership and the ability to thrive in a fast paced environment.