Regulatory Affairs Manager Role
This is a permanent position based in our Cork site, focusing on complex projects within CEOT and EAR scope.
Key Responsibilities:
* Lead and direct project implementation, overseeing all aspects from initiation to completion.
* Ensure compliance with European Medical Device Regulations (MDR) for Stryker products.
* Develop and apply intermediate knowledge of RA frameworks.
* Maintain regulatory obligations and ensure timely market access in EU countries.
Specific Tasks:
* Review technical documentation, including labelling and instructions for use against EU MDR requirements.
* Collaborate with international manufacturing sites to resolve issues.
* Post finalised documentation and review checklists to a central repository.
* Evaluate and escalate EU MDR regulatory compliance gaps and potential patient safety issues.
* Support the maintenance of EAR QMS.
Requirements:
* Equivalent to BS or higher degree.
* 4+ years of work experience.
The ideal candidate will have strong leadership and project management skills, as well as excellent communication and analytical abilities. They must also be familiar with European Medical Device Regulations and have experience working in a similar role.