Regulatory Affairs Lead
Fast paced multinational medical device company whose Galway site primarily specialise in the design and manufacturing of guidewires. They have a fantastic flexitime policy with a fast-paced manufacturing environment which will give employees plenty of opportunities to progress and gain lots of experience as they grow.
- Provide leadership for the site on any device design change.
- Complete submissions for CE Marking Registration, 510(k) registration and PMAs.
- Oversee the completion on technical dossiers, regulatory annual reports, supplements and registrations.
- Lead the regulatory preparation for the site for FDA, ISO13485, Customer and Corporate audits.
- Advise on certain customer complaints and investigations.
- Support queries coming from other sites or notified bodies.
- Answer customer regulatory requests and complaints.
- Support validation documentation programs.
- Review technical files for compliance to relevant medical device requirements.
- You will supervise the development of the QMS and change control process ensuring compliance to 21 CFR 820, MDR, MDD, ISO13485 and ISO14971
- Level 8 degree in engineering, science or relevant field.
- Must have 4 years previous experience in regulatory affairs.
To apply for this position please contact James Porter at Sigmar Recruitment T: +353 91 455305 E: firstname.lastname@example.org
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