Job Description
A highly experienced Regulatory Affairs Specialist is sought to join a key role in Galway.
This role will work closely with cross-functional teams to obtain regulatory approvals for a new medical device therapy.
* Support and advise the Quality leadership on regulatory activities and strategies.
* Develop and submit high-quality regulatory documents to ensure timely product clearance/approval.
* Collaborate with development teams to ensure data quality and submission goals are met.
* Manage product design and technical documentation in compliance with relevant regulations.
* Monitor emerging legislation and guidance, ensuring company-level awareness and compliance.
Required Skills and Qualifications
* Bachelor's or Master's degree in a scientific or engineering discipline.
* At least 7 years' experience in Quality Assurance or Regulatory Affairs for medical device companies.
* Strong experience preparing and reviewing regulatory submissions.
* Collaborative team player with knowledge of medical device design and development.
* Excellent communication, presentation, and analytical skills.