Senior Regulatory Affairs Specialist (m/f/d)
Job Details
Full Job Description
Work Flexibility: Hybrid
The Sr. Regulatory Affairs Specialist (CEOT) Central Economic Operator Team is responsible for verifying compliance to the European Medical Device Regulations (MDR) for Stryker products, developing and applying intermediate knowledge and understanding of RA frameworks, ensuring fulfilment of regulatory obligations and timely market access in EU countries.
K ey responsibilities :
Review technical documentation, including labelling and instructions for use, to ensure compliance with EU MDR requirements.
Collaborate with international manufacturing sites to address and resolve any issues related to technical documentation.
Post finalized technical documentation and review checklists to a central repository for easy access and reference.
Facilitate Regulatory Affairs (RA) flag release for EU MDR compliant products in relevant ERP systems.
Report compliance metrics to the Senior Regulatory Affairs Manager and CEOT and work with the EMEA Regulatory Affairs and Quality Assurance (RAQA) team to plan and execute documentation reviews within specified timeframes.
Escalate any regulatory compliance gaps and potential patient safety issues to the Senior Regulatory Affairs Manager, CEOT and international manufacturing sites promptly.
Implement regulatory strategy for the EAR Quality Management System (QMS).
Provide support to the EMEA product registration team as needed.
Foster close collaboration with local RAQA teams across EMEA and international manufacturing sites to ensure timely documentation reviews and product releases in EU countries.
Executes OneClick maintenance.
What are we looking for:
You have completed BS in Engineering, Science, or related degree; or MS in Regulatory Science; RAC(s) is preferred.
You have gained a minimum of 2 years’ experience in medical technology or another regulated sector in the area of quality, regulatory affairs or R&D.
You have strong time management, coordination, and communication skills, capable of executing basic regulatory tasks and demonstrating a proactive approach to work within a dynamic regulatory environment.
Your English language skills enable you to collaborate with colleagues and stakeholders on a global basis as well in the local office. German is a preference.
Diversity is important to us. We welcome applications from people regardless of their ethnic, national or social origin, gender, disability, age or sexual identity.
Additional information
Thanks to our flexible working hours model, you will have the opportunity to work partially from the home office. A regular presence on site at our location in Cork should always be given to build sustainable relationships and maintain personal contact with colleagues as well as the departments .
Please note that the internal job title may differ from the ad title.
Travel Percentage: None