Regulatory Affairs Specialist CEOT
The Regulatory Affairs Specialist (Central Economic Operator Team) is responsible for verifying compliance to the European Medical Device Regulations (MDR) for Stryker products, ensuring fulfilment of regulatory obligations and timely market access in EU countries.
Your key responsibilities:
Reviews technical documentation including labelling and instructions for use against EU MDR requirements and works with international manufacturing sites to resolve issues.
Post finalised technical documentation and review checklists to a central repository.
Facilitates RA flag release for EU MDR compliant products in relevant ERP systems.
Reports compliance metrics to the Sr Regulatory Affairs Manager, EMEA and works with the EMEA RAQA team to plan and deliver documentation reviews to specified timeframes.
Escalates EU MDR regulatory compliance gaps and potential patient safety issues to the Sr Regulatory Affairs Manager, EMEA and international manufacturing sites in a timely manner.
Provide administrative support to the EMEA product registration team where required.
Develop close collaboration with local RAQA teams across EMEA and international manufacturing sites to ensure timely documentation reviews and product release in EU countries.
What are we looking for?
Fluent in English.
Ideally educated to university degree level.
Candidates should be experienced within Regulatory Affairs, preferably within the Medical Devices field.
Regulatory experience or equivalent within a regulatory compliance function within a similar environment.
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.
Work From Home: No
Travel Percentage: None