Regulatory Affairs Specialist

Life. Unlimited. At Smith+Nephew we design and manufacture technology that takes the limits off living .

We are currently searching for a Regulatory Affairs Specialist who will support with g lobal registration and maintenance of submission of medical devices (EU – risk classes III – I) for a legal manufacturer, covering regulatory support and topics , implementation of global regulations as well as coordination within external authorities/notified body.

What will you be doing?

• Handling and maintenance of regulatory (re-)submissions in EU according to Medical Device Regulation 2017/745 (MDR) of Smith&Nephew Orthopaedics AG products main contact to the notified body .
• Ensure compliance to global regulations 2017/745, EN ISO 13485, Medical device single audit program (Australia, Brazil, Canada, Japan and US) and other relevant regulations and standards.
• Regulatory maintenance and coordination of regulatory (re-)submission of Smith&Nephew Orthopaedics AG products worldwide - collaboration with country affiliates and health authorities
• Coordination of our RA SNOAG Change management and support in design questions, intern and global.
• Technical file support for our products.
• Ensure coverage of the regulatory requirements for a quality management system for medical devices of Smith &Nephew suppliers/contractors and country representatives – contract management and authorizations
• Regulatory support and implementation of global processes (harmonization)

What will you need to be succesful?

• 5 years’ experience in the fields of Regula tory Affairs
• Experience in the regulatory affairs field of medical devices eg (EU MDR ) 2017/745 and MDSAP countries and other global regions
• Excellent communication and collaboration skills
• Able to handle complex projects incl. coordination of project team members .
• Able to independent working.

• Stay connected by joining our Talent Community .
• We're more than just a company - we're a community! Follow us on LinkedIn to see how we support and empower our employees and patients every day.
• Check us out on Glassdoor for a glimpse behind the scenes and a sneak peek into You. Unlimited. , life, culture, and benefits at S+N.
• Explore our website and learn more about our mission, our team, and the opportunities we offer.
• Stay connected by joining our Talent Community .
• We're more than just a company - we're a community! Follow us on LinkedIn to see how we support and empower our employees and patients every day.
• Check us out on Glassdoor for a glimpse behind the scenes and a sneak peek into You. Unlimited. , life, culture, and benefits at S+N.
• Explore our website and learn more about our mission, our team, and the opportunities we offer.