Hot Regulatory Affairs Jobs

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,

Project Manager - Vigilance

We’re currently recruiting for an exciting opportunity with an award-winning Medical Device organization based in Cork. 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 • Develop a coordinated plan to advance strategic projects in alignment with internal and external stakeholders. • Ensure development and attainment of project objectives, along with defining success measures. • Implement a governance structure and actively engage and communicate with executiv...

Location: Cork,

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,

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,

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

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

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,