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.
- Is an effective team leader, fully motivated to achieve and demonstrate best practices in line with the goals of the regulatory department.
- Interfaces with manufacturing, engineering, R&D and quality representatives to provide consultation on the impact of proposed changes to product, processes and the quality system.
- Act as a team member in product development programmes and demonstrates a good understanding of the PDP process.
- Maintains and enhances cross-functional team relationships.
- Review applicable Corporate SOP’s for effect on local regulatory processes and systems.
- Prepare and maintain Technical Files and Design Dossiers.
- Prepare and maintain FDA submissions including IDEs, 510k's and PMAs.
- Review and approve documentation related to product release.
- Provide input, review and approve artwork for labelling and DFU’s
- Participate in Regulatory body audits, such as FDA, Notified Bodies, Competent Authorities and other global regulatory agencies.
- Liaise and provide support to international regulatory colleagues.
- Demonstrate and actively promote highest level of professional regulatory discipline.
- Liaises with both middle and senior management on any regulatory issues relating to their area.
- Bachelor’s Degree in Engineering, Science or Quality Assurance
- Experience in FDA regulations, ISO 13485 and the Medical Device Directive is required
- Good administrative/organisational ability with attention to detail is required
- Technical writing qualification desirable
For further information on this Senior Regulatory Affairs Specialist role in Galway please contact Bimi Felix on 086 8395533 / email@example.com
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