
Senior Medical Device Compliance Specialist
4 days ago
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.
- 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.
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