regulatory

Galway

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

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...

, 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...

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...

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...

and documentation to uphold regulatory standards and site...

of regulatory requirements and quality systems in a medical...

and shelf life data for regulatory submissions to support... design change approval. Interface with Regulatory...

products for Regulatory Submission, Implementation..., Quality/Regulatory or related function, preferably...

. Regulatory Compliance: Ensuring compliance...