Telephone: 086 8395533
Senior Regulatory Affairs Specialist
Our client, a medical device company in Galway is currently looking to recruit a Senior Regulatory Affairs Specialist for their site.
- Determines regulatory pathways for various projects including product classification and subsequent regulatory submission to Regulatory agency/Distributor as required.
- Construction of Technical Files and associated documentation and/ or regulatory rationales.
- Identifies guidance documents, international standards, Consensus Standards and assists teams with their interpretation.
- Interacts with various levels of management, external agencies and companies.
- Analyses and makes recommendations regarding field complaints.
- Remains current on developing regulations and revision of systems for continued compliance.
- Participates in and assists with facility inspections, Notified Body Audits, TGA and other inspections/ audits as required.
- Assists with supervision of department staff, as required.
- Performs other related duties and tasks, as required.
- Education and experience equivalent to a Bachelor's Degree in a technical field such as the biological, physical, engineering or material science disciplines and six years of related industry experience.
- Demonstrated knowledge of the Medical Devices Directive (Preferable) (93/42/EEC, as amended), U.S. FDA regulations and various Quality System Standards/Regulations/Laws, including but not limited to ISO 13485, etc.
- Demonstrated and verifiable experience with authoring regulatory submissions and interacting with reviewers.
- Self-motivated, self-directing, strong attention to detail and excellent time management skills.
- Strong interpersonal skills and the ability to communicate well -- verbally and in writing -- with others.
- Demonstrated computer skills preferably spreadsheets, word processing, database, internet research and other applicable software programs.
For further information on this Senior Regulatory Affairs Specialist role in Galway please contact Bimi on 086 8395533 / firstname.lastname@example.org
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