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

Regulatory Affairs Manager (EMEA)

A Regulatory Affairs Manager (EMEA) is required to join a leadingMedical Device organisationin Athlone . Your role: As the Regulatory Affairs Manager you will be responsible for determining and supporting the regulatory activities which lead to, and maintain regulatory compliance and approval for company products globally. Your responsibilities: Primary responsibility for regulatory affairs in the EMEA region. Pursue relevant information pertaining to new developments in regulatory affairs by maintaining contact w...

Location: Roscommon,
Regulatory Affairs Manager (EMEA)
Roscommon Not Disclosed

Regulatory Affairs Project Leader

We’re currently recruiting for an exciting opportunity with an award-winning Medical Device organization based in Cork . The Regulatory Affairs Project Leader is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do. Your duties: As the Regulatory Affairs Project Leader, you will serve as a technical expert on Regulatory Affairs matters and will be responsible for providing assistance in the preparation and submission of global regulatory documents with little to no supervision. You may act as a team le...

Location: Cork,
Regulatory Affairs Project Leader
Cork 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
Senior Associate Regulatory Affairs Dublin Not Disclosed
Senior Associate Regulatory Affairs Dublin Not Disclosed
Senior Associate Regulatory Affairs Dublin Not Disclosed
GMP Inspector (Compliance ) Dublin Not Disclosed
Scientific Communications Publication Capability Lead Cork 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