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 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.  Stay connected by joining our [Talent Community](https://smithnephew.wd5.myworkdayjobs.com/External/page/4ba17039009510002b17ea5e89c40000). We're more than just a company - we're a community! Follow us on [LinkedIn](https://www.linkedin.com/company/smith-&-nephew/) to see how we support and empower our employees and patients every day.   Check us out on [Glassdoor](https://www.glassdoor.com/Overview/Working-at-Smith-and-Nephew-EI_IE10233.11,27.htm) for a glimpse behind the scenes and a sneak peek into **You. Unlimited.**, life, culture, and benefits at S+N. Explore our [website](https://www.smith-nephew.com/en/) and learn more about our mission, our team, and the opportunities we offer.  Stay connected by joining our [Talent Community](https://smithnephew.wd5.myworkdayjobs.com/External/page/4ba17039009510002b17ea5e89c40000). We're more than just a company - we're a community! Follow us on [LinkedIn](https://www.linkedin.com/company/smith-&-nephew/) to see how we support and empower our employees and patients every day.   Check us out on [Glassdoor](https://www.glassdoor.com/Overview/Working-at-Smith-and-Nephew-EI_IE10233.11,27.htm) for a glimpse behind the scenes and a sneak peek into **You. Unlimited.**, life, culture, and benefits at S+N. Explore our [website](https://www.smith-nephew.com/en/) and learn more about our mission, our team, and the opportunities we offer.