Regulatory Affairs Specialist (60%)
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 global 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 Regulatory 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.
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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.