Jr RA Specialist, Italy (EU MDR)
- Rome, Italy
About Stryker Stryker is one of the world's leading medical technology companies and, together with our customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes.
We are proud to be named the #5 World's Best Workplaces and a Best Workplace for Diversity by Fortune Magazine. Learn more about our award-winning organization by visiting stryker.com
Why regulatory affairs/quality assurance at Stryker? Are you interested in working for a global company where you can work across functions and on a wide-variety of projects? As a member of Stryker's RA/QA team, that is exactly what you will do! Here, we provide our Regulatory Affairs team the opportunity to learn new things, as well as endless growth opportunities. If you are interested in working at one of the World's Best Workplaces, apply now!
Need another reason to apply? Here are 10 reasons to join our Regulatory Affairs team: https://www.strykercareersblog.com/post/10-reasons-to-join-strykers-regulatory-affairs-team
The Jr Regulatory Affairs Specialist (EU MDR) is responsible for in country re-registrations under Stryker's EU MDR transition programme, verifying compliance to the EU MDR for Stryker products, ensuring fulfilment of regulatory obligations and timely market access in EU countries or countries that rely on CE marking for product registration purposes. This is a 12mth contract role.
If this role is of interest, please send a copy of your CV in English.
- Obtains product registration dossiers from international manufacturing sites / EU MDR Central Economic Operator Team and tailor them to meet country registration requirements.
- Develop close collaboration and communication with international manufacturing sites / EU MDR Central Economic Operator Team to ensure timely dossier submission and in-depth understanding of local regulatory requirements.
- Communicate with Stryker consultants and distributors to track and ensure timely dossier submission.
- Review product change requests related to EU MDR which may impact existing or ongoing registrations and product supply.
- Review country specific registration documentation from manufacturing sites and ensure compliance with local in country regulations.
- Maintain EU MDR product registration records and facilitate RA flag release for EU MDR compliant products in relevant ERP systems to ensure timely market access.
- Reports registration metrics to RAQA management and works with the EMEA RA team to plan and deliver documentation reviews to specified timeframes.
- Escalates EU MDR regulatory compliance gaps and potential patient safety issues to the EMEA RA Management and international manufacturing sites in a timely manner.
- Communicate EU MDR related impact on in country registrations / market access to EMEA RA management in timely manner.
Key requirements for the role:
- Fluent in English & Italian.
- Educated to university degree level (Business / Legal / Life Sciences preferred).
- Experience in a medical device regulatory role preferable.
- Sound understanding of EU MDR requirements and obligations preferable.
- High attention to detail and process consciousness.
- Versatility, flexibility and willingness to work with changing priorities.
- Strong organisational, problem-solving and analytical skills.
- Ability to work in a rapidly changing environment.
- Ability to handle multiple projects and meet deadlines, working closely with RAQA Specialists and Managers across the region.
- Strong IT skills, including Microsoft Office Suite.
Our benefits Our total rewards offering varies by country but often includes bonuses; commissions; healthcare; insurance benefits; retirement programs; stock based plans; paid time off plans; family and parenting leaves; tuition reimbursement; wellness programs; onsite fitness centers and cafeterias; discount purchase programs; and service and performance awards - not to mention various social and recreational activities.
Know someone at Stryker? Be sure to have them submit you as a referral prior to applying for this position. Learn more about our employee referral program at https://careers.stryker.com/referrals/
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