regulatory jobs in 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...

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...

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...

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...

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...

documentation, database management, regulatory compliance, and internal coordination. This role... stakeholders when required. Support the team with audit preparation and regulatory compliance...

and regulatory body directives. Ensure all laboratory analysis is carried out in a safe, efficient..., Manufacturing and Regulatory). Proficient computer skills (Excel, Word, PowerPoint, databases...

best practice is adopted in accordance with current GLP, GMP and regulatory body directives. Ensure... with other departments (Analytical, Quality, Manufacturing and Regulatory). Proficient computer skills (Excel...

across international regulatory standards, and leading a team of dedicated quality professionals... regulatory requirements including 21 CFR 820, ISO 13485, MDR, RDC ANVISA 16/2013, MHLW MO 169...