Regulatory Compliance Specialist
4 days ago
We are seeking a highly skilled Regulatory Compliance Specialist to join our client's team. As a key member of the Quality Assurance team, you will be responsible for ensuring that all processes are maintained in support of the company's licenses and authorizations.
This role involves working closely with cross-functional teams to ensure compliance with EU GMP and GDP requirements. You will be responsible for reviewing and approving Non-Conformances (NC), CAPA, change controls, and complaints, as well as ensuring batch record review to verify compliance with GMP and Market Authorization prior to batch release.
Key responsibilities include:
- Reviewing and approving quality documents, including SOPs and Quality System documents
- Maintaining quality processes in support of BLIL authorizations
- Ensuring processes are maintained in support of BLIL as MAH
The ideal candidate will have a BSc (Hons) in Science or equivalent and a minimum of 5 years' experience working in Quality Assurance in the Health Care Industry. They will also have a thorough working knowledge of GMDPs and regulatory expectations for medicinal products and medical devices.
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Regulatory Compliance Specialist
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Regulatory Compliance Specialist
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Regulatory Compliance Specialist
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Regulatory Compliance Specialist
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Regulatory Compliance Specialist
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Regulatory Compliance Specialist
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Dublin, Dublin City, Ireland Eakin Healthcare Group Full timeAbout UsEakin Healthcare Group is a leading provider of innovative medical devices that make a real difference in people's lives. With over 700 colleagues across three manufacturing sites and 12 sales and distribution centers, we are proud to export our products to over 60 countries through a network of 40 distributors and our own offices in Japan, The...
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Regulatory Compliance Specialist
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Dublin, Dublin City, Ireland Ramboll Group AS Full timeRamboll is a people company that delivers innovative solutions within Environment & Health, Water, Energy, and Planning & Urban Design. We are seeking a Regulatory Compliance Specialist to join our team in Dublin, Ohio.In this role, you will be responsible for ensuring that our clients' activities comply with relevant environmental regulations and laws. You...
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Dublin, Dublin City, Ireland Sigmar Recruitment Full timeJob OverviewThe role of a Regulatory Compliance Specialist is to ensure that medical products procured, stored, transported, and sold by all companies operating in Ireland, UK, and Switzerland meet regulatory requirements.Main ResponsibilitiesMaintain product registrations in all territories for the company.Act as EU Authorised Representative (EUAR) for...
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