Life. Unlimited.AtSmith+Nephewwe 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&NephewOrthopaedics 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?
5years’ experience in the fields of Regulatory Affairs
Experience in the regulatory affairs field of medical deviceseg(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.
Smith+Nephew is a global medical technology company. We design and manufacture technology that takes the limits off living. We support healthcare professionals to return their patients to health and mobility, helping them to perform at their fullest potential.
From our first employee and founder, T.J. Smith, to our team today, it’s our people who make Smith+Nephew a unique place.
Yes, we love to innovate and develop exciting technologies, and we offer competitive salaries and progressive benefits. But it’s our culture - of Care, Collaboration and Courage - that really sets us apart.
Through a spirit of ownership and can-do attitude, we work together to win..
We’re a company of people who care about each other, about our customers and their patients, and about our communities.
Together, we fulfill our shared purpose of Life Unlimited.
Please note: not all products referred to may be approved for use or available in all markets.
