Hot Regulatory Affairs Jobs

Scientific Officer (Veterinary)

Scientific Officer (Veterinary) Our client, a large regulatory body, are currently recruiting for a Scientific Officer (Veterinary) to join their team. This is a six month contract and you must be available to start immediately. This role is hybrid working, 3 days in the office (Dublin city centre) and two days working from home. Responsibilities Evaluation of routine applications for variations of product marketing authorisation Evaluation and finalisation of labelling, public assessment reports and related aspects of applications for marketing auth...

Location: Dublin,

Microbiology Manager

Our client is a leading Irish Pharmaceutical organisation in the area of Animal Health. Since their inception, over 40 years ago, they have succeeded in manufacturing, registering and marketing a diverse range of products in over 40 countries worldwide. Their products range from sterile injectables, intramammary, anthelmintics, oral powders, premixes and nutritional supplements providing cost-effective superior treatments for a range of conditions. They are currently looking for a microbiologist to supervise the microbiology department and act as the manager for the unit. ...

Location: Cavan,

Senior Regulatroy Affairs Specialsit

Senior Regulatory Specialist Our client a well funded high potential medical device start up are currently seeking experienced regulatory professional top join their team. The Senior Regulatory Affairs Specialist will work closely with a cross-functional team to obtain the regulatory approvals/clearances needed to support clinical and commercial use of an innovative new therapy. Role/Responsibilities Support and advise the VP Quality and Regulatory Affairs by executing regulatory activities and developing regulatory strategies to support...

Location: Galway,

Quality Lead and DRP

Quality Lead and DRP Location: South Dublin My client provides outsourced and specialised services to its clients, leveraging the strong relationships with 200+ of the world’s best known pharmaco-medical manufacturers across multiple geographies, enabled by our cutting-edge digital technology and our expert teams. The company is organised into three key divisions: Supply Chain & Retail, Commercial & Clinical (Med Tech / Pharma) and Product Access. Culture We pride ourselves in being truly entrepreneurial, innova...

Location: Dublin, Dublin South,

Director, Vendor Quality Management (Clinical)

Our client is a global Biopharma with Centre of Excellence in Dublin for Clinical Trials. Their R&D Quality and Medical Governance (Q&MG) division is seeking a Director, Vendor Quality Management (VQM) to join their high-performing team that supports Clinical Development & Post Marketing programs. In this role you will be responsible for providing quality advice, direction, and leadership for quality and compliance oversight of GxP vendors. You will partner closely with business functions in applying a risk-based approach to key vendor activities which ...

Location: Dublin,

Quality Systems Manager

Role: Quality Systems Manager Location: Newenham Court, Malahide Team: 8 direct reports Hybrid working: 2-3 days a week on site per week Benefits: Competitive salary, 10-15% bonus, pension and full family healthcare Day to day: Manage and maintain the Quality Management System for GDD - ensuring compliance is maintained against ISO 13485: 2016, 21 CFR 820 (and relevant territorial Quality System requirements as they arise within the organization); Monitor the performance of the QMS and implement necessary remediation activities to ensure steady state ...

Location: Dublin, Dublin City Centre, Dublin Greater, Dublin North, Dublin South,

Quality Engineer

Role: Quality Engineer Location: Athone, Westmeath Benefits: Excellent salary, pension healthcare and yearly bonus Contract length: 24 months based on site Company: Multinational Medical Device company focussing on the development of cutting-edge medical devices in Airway Management but also for other life enhancing applications. Responsibilities: - Develops, modifies, applies, and maintains quality standards and protocols for processing materials into...

Location: Midlands, Roscommon, Westmeath,

Medical Device Director

Our 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,

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,

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 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,