regulatory jobs in Co Galway

Director of Regulatory Affairs – Medical Device Start-Up – Galway About the Company... and internationally. The Opportunity We are seeking a Director of Regulatory Affairs...

for compliance with medical device regulatory standards for all aspects of the program. You work...

with safety and regulatory standards Collaborate across teams to resolve technical challenges...

to technical community. Interpret evolving global regulatory and standard requirements and assess..., quality, manufacturing, regulatory, clinical and marketing to ensure project success. Work...

with Regulatory Authorities for audits and presenting to senior leadership above country.../CAPA teams, aligning with corporate objectives and global regulatory standards (FDA, HPRA...

to technical community. Interpret evolving global regulatory and standard requirements and assess..., quality, manufacturing, regulatory, clinical and marketing to ensure project success. Work...

control and regulatory requirements Define, negotiate, and coordinate resource needs...

. Liaise with project managers, site supervisors, and regulatory bodies as required. Candidate...

. Liaise with project managers, site supervisors, and regulatory bodies as required. Candidate...

-cycle ERP projects and is adept at aligning system implementations with regulatory compliance.../consultants to ensure alignment and accountability. Ensure strict adherence to regulatory standards...

contribution to team productivity Compliance with legal, regulatory and policy requirements... others) Regulatory Requirements: This role is subject to the Fitness and Probity Standards (“The...

changes to meet business needs in line with updated standards and regulatory requirements... and assess product impact with integration into QMS as required. Understand the Regulatory...

regulatory standards and site procedures at every step. Support scheduling and execution...

of regulatory requirements and quality systems in a medical device environment. Committed to ethical...

& will participate in the compilation of design verification and shelf life data for regulatory submissions... to support design change approval. Interface with Regulatory Affairs to ensure information...

Experience of Microsoft Word and Excel desirable but not required Regulatory Requirements...

implementation of safety programs. Regulatory Compliance: Ensuring compliance with all relevant...

areas and regions. Responsible for leading approx. 80 products for Regulatory Submission... of experience in Project Management, Operations, Manufacturing, Supply Chain, Quality/Regulatory...

regulatory requirements and statistical data analysis. Demonstrate a motivated & flexible approach...

with our policies and procedures Complying with risk control and regulatory requirements... and organisation skills Comply with risk control and regulatory requirements that are relevant...