Mercury Medical
Director of Regulatory Affairs and Quality Assurance
Mercury Medical, Clearwater, Florida, United States, 34623
Overview
Director of Regulatory Affairs and Quality Assurance at Mercury Medical. Responsible for design and implementation of policies and procedures related to medical devices to ensure quality and regulatory standards are met; that company products meet defined and documented specifications; and that they comply with applicable Federal, State and International regulations and standards governing the medical device industry, including but not limited to FDA, MDR, ISO, UL, OSHA, EPA, ASTM, ANSI. Responsibilities
Lead and direct the works of others in Regulatory Affairs and Quality Assurance to maintain compliance with applicable regulations and standards. Design and implement policies and procedures for medical devices to ensure quality and regulatory compliance. Oversee regulatory submissions (510(k)s) and technical files; manage documentation to meet regulatory requirements. Ensure products meet defined specifications and that processes comply with FDA QSR (21 CFR 800-860), EU MDR, MDSAP, ISO, and applicable standards and regulations (ASTM, UL, CSA, ANSI, EPA, etc.). Coordinate with internal teams to prioritize, organize, and delegate assignments across multiple tasks and projects; manage timelines and resources effectively. Adequate understanding of related regulatory requirements and ability to travel for supplier audits as needed. Qualifications
Bachelor's degree from an accredited college or university; 10 years of related medical device experience, or an equivalent combination of education and experience; advanced degree a plus. Experience in regulatory submissions (510(k)) and technical files is a plus. ASQC CQM certification a plus. Thorough understanding of FDA QSR (21 CFR 800-860), EU MDR, MDSAP, ISO, and related standards; knowledge of ASTM, UL, CSA, ANSI, EPA, and U.S. Customs Regulations as applicable. Ability to prioritize, organize, and delegate assignments; capable of handling multiple tasks/projects simultaneously. Must be able to commute to Clearwater, FL 33762 (Required); ability to travel to conduct supplier audits. Benefits
401(k) with company match Health, dental, and vision insurance Employee assistance program Flexible spending account Health savings account Life insurance Paid time off: 40 hours after 90 days, and 40 hours after six months in year 1 Schedule: on-site; 8-hour shifts, Monday to Friday.
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Director of Regulatory Affairs and Quality Assurance at Mercury Medical. Responsible for design and implementation of policies and procedures related to medical devices to ensure quality and regulatory standards are met; that company products meet defined and documented specifications; and that they comply with applicable Federal, State and International regulations and standards governing the medical device industry, including but not limited to FDA, MDR, ISO, UL, OSHA, EPA, ASTM, ANSI. Responsibilities
Lead and direct the works of others in Regulatory Affairs and Quality Assurance to maintain compliance with applicable regulations and standards. Design and implement policies and procedures for medical devices to ensure quality and regulatory compliance. Oversee regulatory submissions (510(k)s) and technical files; manage documentation to meet regulatory requirements. Ensure products meet defined specifications and that processes comply with FDA QSR (21 CFR 800-860), EU MDR, MDSAP, ISO, and applicable standards and regulations (ASTM, UL, CSA, ANSI, EPA, etc.). Coordinate with internal teams to prioritize, organize, and delegate assignments across multiple tasks and projects; manage timelines and resources effectively. Adequate understanding of related regulatory requirements and ability to travel for supplier audits as needed. Qualifications
Bachelor's degree from an accredited college or university; 10 years of related medical device experience, or an equivalent combination of education and experience; advanced degree a plus. Experience in regulatory submissions (510(k)) and technical files is a plus. ASQC CQM certification a plus. Thorough understanding of FDA QSR (21 CFR 800-860), EU MDR, MDSAP, ISO, and related standards; knowledge of ASTM, UL, CSA, ANSI, EPA, and U.S. Customs Regulations as applicable. Ability to prioritize, organize, and delegate assignments; capable of handling multiple tasks/projects simultaneously. Must be able to commute to Clearwater, FL 33762 (Required); ability to travel to conduct supplier audits. Benefits
401(k) with company match Health, dental, and vision insurance Employee assistance program Flexible spending account Health savings account Life insurance Paid time off: 40 hours after 90 days, and 40 hours after six months in year 1 Schedule: on-site; 8-hour shifts, Monday to Friday.
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