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Search Results for Regulatory Affairs Manager
Job Title. Location Salary Actions

Senior Regulatory Affairs Specialist

Would you like to join a leading medical device company in Galway, in a regulatoey affairs role? If you have previous Regulatory Affairs experience working with class III medical devices, this could be the role for you. RESPONSIBILITES Responsibilities may include the following and other duties may be assigned. Directs or performs coordination and preparation of document packages for regulatory submissions. Teams with business unit Regulatory Affair Specialists and international regulatory staffs to provide regulatory support for new products/therapies and changes to ex...

Location: Galway,
Senior Regulatory Affairs Specialist
Galway Not Disclosed

Regulatory Affairs Specialist

Our client a medical device early stage company wishes to add a Regulatory Affairs Specialist to our team. The successful candidate will work with the Design, Quality and Regulatory teams to support all regulatory functions for both existing and new products. Role/Responsibilities • Contribute to the regulatory strategy plans for new products, including required Regulatory Agency approvals. • Provide regulatory input into labelling, test strategies for new product development, risk analysis, clinical, preclinical and marketing issues. • Planning,...

Location: Cork,
Regulatory Affairs Specialist
Cork Not Disclosed

Regulatory Affairs & Quality Manager

Regulatory Affairs & Quality Manager Our client a cardiovascular medical device start-up looking to hire a Quality and Regulatory Affairs manager. The succ

Location: Dublin,
Regulatory Affairs & Quality Manager
Dublin Not Disclosed
Other Regulatory Affairs Jobs
Job Title Location Salary Actions
Regulatory Affairs Specialist (LOA007553) Dublin Not Disclosed
Director, PVE (Risk Management) Dublin Not Disclosed

Regulatory Affairs Manager Career Profile

Regulatory Affairs Manager

This role is normally suited to someone with a minimum of 5 years in a Regulatory setting, ideally more. Management, departmental budgeting, training are some of the keys tasks involved on the non-technical side of the role.

Key Responsibilities

  • Coordinating, compiling and submitting Marketing Authorisation variations for existing approvals
  • Composing and reviewing Pre-IND information packages and NDA packages for registration of prescription products in the US through the FDA
  • Liaise with partner companies as the primary Regulatory Affairs contact for the company to achieve product registration in all new worldwide regions within projected timeframes
  • Regulatory Affairs European project team leader for all new projects
  • Interpreting EU and US regulatory guidelines and procedures and ensuring the regulatory compliance of the company in all new regions Establish and analyse department budget
  • Identify and recommend areas for cost savings from and Regulatory and compliance perspective
  • Provide Regulatory advice and feedback for all internal company departments and external partners
  • Maintain and apply a high level of awareness and understanding of the impact of existing and future planned regulations