regulatory

Co Galway

Director of Regulatory Affairs – Medical Device... of Regulatory Affairs with a strong strategic vision...

) is a plus. Regulatory & Systems Knowledge: Familiarity with IVDD/IVDR...

that satisfy customer and regulatory requirements...

persons for documentation, quality, and regulatory...

in regulatory and customer audits and coordinate the timely..., regulatory audits, supplier audits, and customer audits...

products meet all regulatory, quality, and safety...

, and regulatory authorities to obtain project approvals...

and associated regulatory requirements. Qualifications...

regulatory standards (IEC 60601-1, IEC 60601-1-2, FDA... System and regulatory submissions (CE marking, FDA 510...

testing and release. Ensuring compliance with Regulatory... and US regulatory requirements. Data integrity is of paramount...

and regulatory standards Collaborate across teams to resolve...

, as well as comfortable with dealing with Regulatory... regulatory standards (FDA, HPRA, DERKA, etc.). Manage the...

evolving global regulatory and standard requirements..., manufacturing, regulatory, clinical and marketing to ensure...

with medical device regulatory standards for all aspects...

and regulatory requirements Define, negotiate, and coordinate...

managers, site supervisors, and regulatory bodies...

managers, site supervisors, and regulatory bodies...

implementations with regulatory compliance and cross-functional... and accountability. Ensure strict adherence to regulatory...

with updated standards and regulatory requirements and assess product... as required. Understand the Regulatory requirements for device...

, regulatory and policy requirements Contributing to the... others) Regulatory Requirements: This role is subject to the...