Senior Regulatory Affairs Specialist
- Work with the national and international regulatory affairs teams to provide support in change management for products and also addressing potential issues and questions for regulatory bodies.
- Prepare regulatory submissions and CE Mark Technical files for NPD and product change projects and activities.
- Addressing MDR and remediation issues and applying all necessary actions across the business portfolios.
- Review documentation for products live in the market in relation to any changes and also interacting with the FDA directly and indirectly plus reviewing with management any significant issues.
- Maintain and update insight database.
- Ensure focus of business and departments on compliance to global regulations and international standards.
- Level 8 degree with 4 years or more experience in QA and RA within a medical device or similarly regulated environment.
- Working knowledge of Medical Device QMS under 21 CFR 820, ISO13483/MDD and MDR
- Would be beneficial to have ISO, GHTF and ICH standards experience.
- Preferable to have experience in medical devices (510(k), PMA), pharmaceuticals, or combination products (drug/biologic-device).
To apply for this position please contact James Porter at Sigmar Recruitment T: +353 91 455305 E: email@example.com
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