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Search Results for for
Job Title. Location Salary Actions

Quality Assurance Specialist

JOM AKEM-015176 Quality Assurance Scientist Location: Co. Galway Reporting to Director Innovation Insights. You will be part of the world leader R&D organisation. You will be responsible of the implementation and compliance to relevant quality system regulations and standards for the R&D organization. In particular, you will play a key role in developing, deploying, and maintaining R&D documentatio...

Location: Galway,
Quality Assurance Specialist 		Galway Not Disclosed

Quality Engineer

JOM AECP-463357 Quality Engineer Location Co Louth RESPONSIBILITIES : Manage and provide guidance on Data Strategies for Change Control process Actively supports site CAPA system, mentors associates on CAPA process, co-ordinates preparation of data for CAPA review Meetings etc. Actively supports internal audit program for the site and identify areas of potential noncompliance or improvements. Be a key member of the onsite audit team during external audits, e.g. from Regulatory Authorities and Global Corporate Quality. Assist and facilitate Complaint invest...

Location: Louth,
Quality Engineer 		Louth Not Disclosed

Clinical Regulatory Associate

Clinical Regulatory Associate Our client, a global pharma company are currently recruiting for a Clinical Regulatory Associate to join their team on a permanent basis. As Clinical Regulatory Associate you will beaccountable for the operational and technical registration management processes that support the expedited delivery of safe and effective products to patients. Responsibilities Lead the registration management process by providing expertise in electronic submission regulations and guidance and technical content for which includes INDs, NDA, BLAs, NDSs, and oth...

Location: Cork,
Clinical Regulatory Associate 		Cork Not Disclosed

Quality Assurance and Regulatory Affairs Compliance officer

Quality 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,
Quality Assurance and Regulatory Affairs Compliance officer 		Sligo Not Disclosed

Regulatory Affairs Technical Manager remote working

Regulatory Affairs Technical Manager 100% remote working Our client, an animal health organisation, are currently recruiting for a Regulatory Affairs Technical Manager to join their team. This is a super opportunity for an experienced Regulatory professional from an animal health or pharmaceutical background to work 100% remotely. Responsibilities Responsible for preparation of the Part 1 and CMC/Part 2 files for dossiers for Marketing authorisations Create and oversee studies needed, including technical/scientific input for pharmaceutical studies needed...

Location: Kerry,
Regulatory Affairs Technical Manager remote working 		Kerry Not Disclosed

Regulatory Affairs Director

Regulatory 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,
Regulatory Affairs Director 		Dublin Not Disclosed

Regulatory Affairs Specialist

Regulatory 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,
Regulatory Affairs Specialist 		Cork Not Disclosed

Regulatory Affairs Specialist

Life 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,
Regulatory Affairs Specialist 		Republic of Ireland Not Disclosed

Senior Regulatory Affairs Specialist

Senior 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,
Senior Regulatory Affairs Specialist 		Westmeath Not Disclosed

Senior Regulatory Affairs Specialist

Senior 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,
Senior Regulatory Affairs Specialist 		Dublin Not Disclosed
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