Farrukh Mohiuddin
Principal Regulatory Affairs Specialist @ZOLL Medical Corporation
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WORK HISTORY
Principal Regulatory Affairs Specialist @ZOLL Medical Corporation
Provide leadership to the regulatory and cross-functional teams on multiple product lines during product development, regulatory submissions,and post-market issues with effective and efficient regulatory strategy. • Interpret regulations, laws, and guidance to establish, implement and monitor policies, procedures and processes to ensure compliance. • Develop and execute sound regulatory strategies for a range of complex existing products and new product development programs, with emphasison regulatory requirements and submissions associated with FDA Class II and Class devices. • Independently prepare global regulatory applications, including U.S. and E.U. MDR Medical submissions (Pre-market Approvals (PMA), PMAAnnual Reports, 510(k)s, E.U. MDR Technical Documentation - Class etc.). • Demonstrate deep knowledge of the EU MDR and ensure applicable requirements are embedded in the QMS. • Support global expansion of products through RoW submissions (i.e, S. Korea, Taiwan, India, Japan, etc.). • Support mergers and acquisitions from a Regulatory standpoint. • Review/approve marketing materials and labeling for regulatory requirement compliance. • Participate in regulatory inspections/audits by internal and external audit authorities.
EDUCATION
Rochester Institute of Technology
BS/MS Dual Degree, Biomedical Engineering and Science, Technology, & Public Policy
ABOUT FARRUKH MOHIUDDIN
Regulatory Affairs professional and Graduate of the dual degree B.S. Biomedical…
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