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| Job Title. | Location | Salary | Actions |
Regulatory Medical WritingAssociate / Sr. Associate - Regulatory - Global Scientific Communications Purpose: Scientific data and information are core assets of the company. Providing balanced, objective, and accurate information to regulators, the scientific community, health care professionals, payers, and patients in a consistent and timely fashion across the entire drug development lifecycle is fundamental to the organisation. The purpose of the Scientific Communications Associate - Regulatory role is to work with cross-functional, multidisciplinary teams to lead the development of doc...Location: Cork, Cork City, |
Cork | Not Disclosed | |
Medical Device DirectorOur client a Medical Devcie notifeid body are currently seeking Director of Medical Devices to join their team. The Director of Medical Devices will have overall leadership repsonsibility for European and US Medical Division and provide leadership and strategic guidance. Role can be based in Dublin or Galway and can provide hybrid Roles/Responsibilities Responsible for European and US Medical Device Division Manage resources for Global Medical Device division Responsible for department KPIs and all certifications filed Oversee global audit team planning Mem...Location: Republic of Ireland, |
Republic of Ireland | Not Disclosed | |
Quality Team LeaderOur client is a leading Healthcare Manufacturing organisation based in Drogheda, Co. Louth. Due to expansion, they are seeking a new Quality Team Leader to join an established team. Reporting to the Quality Manager, the Quality Team Leader will always champion quality standards across both sites, whilst leading the Quality Team. This person will also support the wider team to ensure products are manufactured right first time and in accordance with the quality protocols, Good Manufacturing Practices (GMP) and ISO standards. The Quality Team Leader will always behave in a manner...Location: Louth, Republic of Ireland, |
Louth | Not Disclosed | |
Regulatory CMC AssociateRegulatory CMC Associate Our client, a global pharma company based in Cork, are currently recruiting for a Regulatory CMC Associate to join their team on a permanent basis with hybrid working. As Regulatory CMC Associate, together with the CMC Regulatory Affairs Scientist you will leads the various aspects of global marketing authorization submission management processes. You will assist in providing guidance on structure and content placement within CTD registration submissions and provide assistance with submission related Ministry of Health responses. Responsibili...Location: Cork, |
Cork | Not Disclosed | |
QA SpecialistWe’re currently recruiting for an exciting opportunity with an award-winning medical device organization based in Meath. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do. Responsibilities. The QA Specialist will work across the site self-directed work teams and hub to identify and resolve issues in order to allow the site to deliver on our COMMIT culture that supports Quality, EHS, Learning and Continuous improvement. This role will provide Quality Assurance (QA) oversight to ...Location: Meath, |
Meath | Not Disclosed | |
Senior Quality Assurance SpecialistWe’re currently recruiting for an exciting opportunity with an award-winning pharmaceutical organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do. Duties • Provide overall quality direction and oversight for processes and procedures related to Technology Transfer/NPI, Product Lifecycle changes, Validation and Engineering ensuring that programs, policies and procedures are robust and in keeping with regulatory and Amgen expectations. • Q...Location: Dublin, |
Dublin | Not Disclosed | |
Regulatory Medical WritingAssociate / Sr. Associate - Regulatory - Global Scientific Communications Purpose: Scientific data and information are core assets of the company. Providing balanced, objective, and accurate information to regulators, the scientific community, health care professionals, payers, and patients in a consistent and timely fashion across the entire drug development lifecycle is fundamental to the organisation. The purpose of the Scientific Communications Associate - Regulatory role is to work with cross-functional, multidisciplinary teams to lead the development of doc...Location: Cork, Cork City, |
Cork | Not Disclosed | |
Bioprocess AssociateWe’re currently recruiting for an exciting opportunity with an award-winning Biopharmaceutical organization based in the north Dublin area. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do. Responsibilities. Work with the manufacturing operations group, project design team, the CQV team, the Automation/CSV reps to facilitate the development and validation of the manufacturing facility. Support Equipment Design/ HAZOP and Room programming reviews. Support Operations team to consisten...Location: Dublin, |
Dublin | Not Disclosed | |
Senior Project EngineerWe’re currently recruiting for an exciting opportunity with an award winning Medical Device organization based in Limerick. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do. Duties −Provide engineering support in developing new or improving existing equipment and/or process related activities. −Define or assist in defining process equipment requirements and specifications based on process requirements, safety requirements and customer needs − Perform p...Location: Limerick, |
Limerick | Not Disclosed | |
Quality Assurance and Regulatory Affairs Compliance officerQuality Assurance and Regulatory Affairs Compliance officer Description/summary of role? • Operational and administrative support for the business on all quality assurance and regulatory compliance • Validation of quality processes, quality management systems & administration •&nb...Location: Sligo, |
Sligo | Not Disclosed | |
Assoc MDR/Vigilance SpecialistWe’re currently recruiting for an exciting opportunity with an award-winning medical device organization based in Galway. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do. You will be part of a high performing Complaint Handling and Medical Device Regulatory reporting department, which provides value throughout the Product Life cycle through world class execution in Medical Device Reporting and Vigilance compliance. Responsibilities Responsible for the co-ordination of complaint ha...Location: Galway, |
Galway | Not Disclosed | |
Regulatory Affairs DirectorRegulatory Affairs Director Our client a global healthcare company is currently seeking a Technical Device Regulatory Affairs Director to join their team. Director will be responsible for all aspects of Regulatory Affairs for their portfolio of devices Role/Responsibilities: Accountable to define device regulatory requirements and regulatory strategy to development teams to ensure readiness for medical device (MD) and combination product (CP) approvals. Critically review, approve, and lead strategy for global regulatory submissions for device compo...Location: Dublin, |
Dublin | Not Disclosed | |
Regulatory Affairs SpecialistRegulatory Affairs Specialist (Remote/Hybrid) Our client a high potential start up medical device company currently seeks a Regulatory Affairs Specialist to join their team. Reporting to the Clinical and Regulatory Affairs Manager, the Regulatory Specialist will be responsible for helping with compliance to standards, regulatory submissions and annual reporting to the notified body and FDA. The Regulatory Affairs Specialist must have a working knowledge of medical device regulatory requirements and standard practices in the medical device industry. This position re...Location: Cork, |
Cork | Not Disclosed | |
MDR/Vigilance SpecialistWe’re currently recruiting for an exciting opportunity with an award-winning Medical Device organization based in Galway. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do. Duties Responsibilities may include the following and other duties may be assigned. Monitors the company's drug or medical devices surveillance program including the intake, protocol development, evaluation, processing, and follow up on adverse reports, participation in the resolution of any legal liability and in...Location: Galway, |
Galway | Not Disclosed | |
Regulatory Affairs SpecialistLife Science Recruitment is hiring for a Regulatory Affairs Specialist to join our clients expanding Life Sciences division. This is a hybrid role, the successful candidates will be responsible for managing Quality Systems, Regulatory Compliance, and support Quality Engineering activities for our clients and work for a variety of products and technologies to ensure compliance with medical device standards and regulations, including: 21 CFR Part 820, ISO 13485, MDD, AIMD, MDR and CMDCAS. Responsibilities: Be a Regulatory Affairs subject ...Location: Republic of Ireland, |
Republic of Ireland | Not Disclosed | |
Senior Regulatory Affairs SpecialistOur client a medical device start up are looking for a Senior Regulatory Affairs Specialist to support the product development of a cutting-edge device through design development, verification, clinical trials, validation and regulatory approvals. This position can be fully remote. Role/Responsibilities Provide regulatory guidance to product development team, working closely with cross-functional team members to develop and implement the regulatory strategy. Lead the development, submission and maintenance of high quality clinical and regulatory files to the relevant...Location: Dublin, |
Dublin | Not Disclosed | |
Senior Regulatory AffairsOur client a growing medical device organisation currently seeks a Senior Regulatory Affairs Specialist to join their team. The Senior Regulatory Affairs Specialist will be responsible for all regulatory activities including product certification and compliance, and for supporting the ongoing maintenance, audit and continuous improvement of specific elements of the Quality Management System Role/Responsibilities Manage the regulatory and vigilance process. Prepare regulatory submissions for required markets coordinating input from other stakeholders, tr...Location: Galway, |
Galway | Not Disclosed | |
Senior Regulatory Affairs SpecialistSenior Regulatory Affairs Specialist Our client a Medical Device Multinational currently seeks a Senior Regulatory Specialist to join their team. The Senior. Regulatory Affairs Specialist will develop strategies and submissions for complex projects and issues related to regulatory documents, submissions, investigations, product development planning and regulatory agency interaction. The Sr. Regulatory position will assist in mentoring and development of staff members as part of the role. Role/Responsibilities • Manage Technical Documentation ...Location: Westmeath, |
Westmeath | Not Disclosed | |
Senior Regulatory Affairs SpecialistSenior Regulatory Affairs Specialist Our client a high potential medical device start up current seeks a Senior Regulatroy Affairs Specialist to join their team. Reporting to the Director of Quality and Regulatory Affairs the Senior Regulatory Affairs will take an active role in developing the Regulatory strategy in Europe and the US and interacting with the relevant Regulatory and Notified Bodies. They will also be required to help maintain the Design History Fileof Class III implant. This position offers the opportunity to join in an exciting early stage company developing a...Location: Dublin, |
Dublin | Not Disclosed |
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Regulatory Affairs | Tel:+353 1 685 4848 | Fax: +353 (0)1 443 05 24 | Email: [email protected]
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Regulatory Affairs | Tel:+353 1 685 4848 | Fax: +353 (0)1 443 05 24 | Email: [email protected]
Copyright © 2012 Life Science Recruitment Ltd
This site uses cookies. For more information on our cookie policy read our Privacy Policy | Terms of Use
Registered as a private limited company. No: 445328 | Web Design / SEO by WebScience | Valid XHTML - CSS