
Regulatory Affairs Specialist
5 days ago
The ideal candidate will have a strong background in regulatory affairs, specifically in medical devices.
Main Responsibilities:- Develop and implement regulatory strategies to ensure compliance with European and US regulations.
- Support the creation and maintenance of product design and technical documentation in accordance with relevant regulations and standards.
- Develop and submit high-quality clinical and regulatory files to ethical committees and regulatory agencies.
- Organise and maintain regulatory submissions with regulatory authorities and clinical investigation sites.
- Coordinate gap assessment activities and stay up-to-date with changes in applicable regulatory requirements.
- Bachelor's degree in science, engineering or related field.
- Proven track record in a similar role with at least 5 years' experience in medical device regulatory affairs.
- Extensive knowledge of quality management systems, design controls and current International and European regulations.
- In-depth knowledge of EU Medical Device Directive and MEDDEV guidance documents.
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Regulatory Affairs Specialist
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Senior Regulatory Affairs Specialist
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Regulatory Affairs Professional
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Regulatory Affairs Senior Specialist
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Dublin, Dublin City, Ireland Xeolas Full timeDublin, Ireland - Permanent Full Time RoleXeolas is an Irish-owned speciality Pharmaceutical company located in Dublin, Ireland with 70+ employees. We develop and manufacture innovative patient-friendly pharmaceutical products for international markets. We are now seeking an experienced Regulatory Affairs Senior Specialist as we expand.Overall Role...
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Senior Regulatory Affairs Specialist
4 days ago
Dublin, Dublin City, Ireland beBeeRegulatoryAffairs Full time €60,000 - €95,000**Job Title:** Senior Regulatory Affairs SpecialistAbout the RoleThis is a unique opportunity to join our team as a Senior Regulatory Affairs Specialist, where you will play a key role in ensuring compliance with global regulations and guidelines for medical devices. As part of our regulatory affairs team, you will be responsible for post-market activities,...
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Regulatory Affairs IT Specialist
2 weeks ago
Dublin, Dublin City, Ireland beBeeRegulatory Full time €90,000 - €120,000Regulatory Affairs IT SpecialistWe're looking for a skilled Regulatory Affairs IT Specialist to join our team. This role involves overseeing the development and implementation of IT solutions that support regulatory compliance across various industries, including pharmaceutical manufacturing, hospitals and healthcare, and biotechnology research.About The...
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Regulatory Affairs Specialist
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Dublin, Dublin City, Ireland beBeeRegulatory Full time €90,000 - €110,000Regulatory Affairs Specialist - Pharmaceutical IndustryThis is a permanent full-time role based in Dublin, with the primary focus on regulatory affairs. The successful candidate will be responsible for ensuring compliance with health authority requirements and regulations.Key ResponsibilitiesThe Regulatory Affairs Specialist will be involved in all aspects...
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Regulatory Affairs Professional
1 week ago
Dublin, Dublin City, Ireland beBeeRegulatoryAffairs Full time €90,000 - €121,000Regulatory Affairs Specialist Job DescriptionThis is a key role in our organization, responsible for post-market activities for Administration and Safety System medical devices. We are seeking an experienced Regulatory Affairs Specialist to join our team.Job Summary:The successful candidate will be responsible for performing post-market surveillance...