As a Staff Regulatory Affairs Specialist based in Cork, you will play a key role in ensuring regulatory compliance for Stryker’s medical devices across global markets. In addition, you will support product transfers between Stryker manufacturing sites and international markets, with a focus on CE Mark submissions and EU MDR compliance.
Reporting to the Regulatory Affairs Manager, you will collaborate with cross-functional teams and regulatory authorities throughout the product lifecycle to ensure timely approvals and ongoing market access.
What you will do:
Develop and execute regulatory strategies to support product transfers and international registrations.
Prepare and maintain regulatory submissions in compliance with EU MDR and other global regulations.
Evaluate technical documentation, clinical and nonclinical data, and labeling for regulatory compliance.
Advise internal stakeholders on requirements for quality, preclinical, and clinical data throughout the product lifecycle.
Monitor changes in global regulatory requirements and update strategies and processes accordingly.
Review proposed product changes and assess their impact on global registrations.
Communicate with global regulatory authorities during submission preparation, review, and post-approval phases.
Support internal audits and regulatory inspections as needed.
What will you need:
Required:
Bachelor’s or Master’s degree in Engineering, Science, or a related field. Master’s degree in Regulatory Science or RAC certification is a plus.
Minimum 4 years of Regulatory Affairs experience in the medical device industry.
Proven experience with EU MDR and CE Marking processes.
Hands-on experience with international product registration and lifecycle maintenance.
Knowledge of Class III and II medical devices, ideally in instruments.
Strong written and verbal communication skills and attention to detail.
Preferred:
Experience supporting product transfer projects between global manufacturing sites.
Familiarity with additional international markets beyond Europe.
Background in sustaining RA for complex device portfolios.
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. However, a regular presence of 2 days a week on site at our location in Cork should be always given to build sustainable relationships and maintain personal contact with colleagues as well as the departments.
Travel Percentage: 10%