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Hot Regulatory Affairs Jobs

Regulatory Affairs Specialist

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Job Title.	Location	Salary	Actions
Clinical Publisher Associate Clinical Publisher Associate Our client, a global pharma company are currently recruiting for a Clinical Publisher Associate to join their team on a permanent basis. As Clinical Publisher you will create and maintain complex strategic and compliance submissions through collaboration, document management, and internal database maintenance. You will collaborate with Regulatory Associates, Regulatory Scientists, cross-functional contributing/authoring areas, and affiliates to align on submission specific strategies and to ensure adherence to eCTD regulations and guide... Location: Cork, Clinical Publisher Associate	Cork	Not Disclosed
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
Senior Project Engineer We’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, Senior Project Engineer	Limerick	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
Assoc MDR/Vigilance Specialist We’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, Assoc MDR/Vigilance Specialist	Galway	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
MDR/Vigilance Specialist We’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, MDR/Vigilance Specialist	Galway	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 Our 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, Senior Regulatory Affairs Specialist	Dublin	Not Disclosed
Senior Regulatory Affairs Our 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, Senior Regulatory Affairs	Galway	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