Sr. Director Quality Assurance & Regulatory Affairs

WHAT YOU'D DOQuality Assurance:

• Provide leadership to the existing Quality Assurance team including managers and individual contributors.
• Assume primary responsibility for implementation and maintenance of all aspects of the company-wide quality management system. Determine and enforce (through functional groups) quality requirements in accordance with FDA QMSR and ISO standards.
• Lead preparation and planning for quality programs to support commercial activities and ongoing compliance, including complaint tracking, investigation, trending and reporting program.
• Direct quality program development with multiple functions (Operations, R&D, Sales & Marketing, external vendors) to assure adequate resources are available to meet project timelines.
• Organize and promote company-wide quality improvement efforts, including setting annual quality objectives.
• Hire, train, and manage QA Staff.
• Advise and consult with internal staff and scientific consultants who contribute to regulatory submissions, ensuring that appropriate information complies with regulatory regulations/standards/guidelines.
• Direct implementation and ongoing management of international complaint handling system; in compliance with FDA MDR and device vigilance reporting regulations.
• Act as or designate QA representative on product development teams (design control and risk management); critically review all documentation for submissions for consistency, accuracy and quality.
• Supervise and provide guidance on day-to-day quality activities including supplier quality/incoming inspection, management review, training, document control, non-conforming material, and corrective and preventive action.
• Supervise and manage internal audits and inspections including FDA, Cal FDB and others.
• Review Change Orders, Design Change Notices, etc., for compliance with FDA, and international regulations and standards.
• Monitor proposed changes in regulations, standards and guidance publications for impact on current and future development strategies.

• Lead and develop a Regulatory Affairs team consisting of external and internal resources.
• Oversee the company’s regulatory filings including IDEs, supplements and amendments, Post marketing studies and reports, marketing submissions including De Novo and 510(k) and ongoing updates and annual/periodic reports for all company submissions.
• Organize and lead projects and subprojects related to RA strategies. May enlist external experts and other resources and manage related actions.
• Responsible for developing and maintaining regulatory affairs operating procedures and work instructions.
• Lead and/or oversee regulatory activities by reviewing study-related documents in accordance with applicable regulations.
• Work with external and internal resources for input and ideas for regulatory strategy to address FDA questions and planning for data framing to highlight Moximed technology advantages and context for risk.
• Act as or designate ‘Responsible Party’ for purposes of submitting information about Moximed’s applicable clinical trials (ACT) on clinical trials.gov in coordination with the Clinical Affairs department.
• Ensure the uniform and timely processing of Moximed Medical Device Reports (MDRs) in accordance with FDA regulations and internal operating procedures.
• Support product development/improvement projects with R&D and Engineering to assure applicable regulatory requirements are met.
• Provide regulatory strategy guidance to clinical and operations departments.
• Lead ad/promo review of product labeling, literature and company websites for accuracy, consistency and domestic and international regulatory compliance.
• Lead activities for State and Federal regulatory licenses, registrations and listings.
• Responsible for obtaining and maintaining FDA Small Business Designation.
• Support review of internal operating procedures and other controlled documents to ensure regulatory and quality compliance and consistency with regulatory commitments.
• Research, prepare and communicate new and changing product regulatory assessments and justifications.
• Assist with the training and development of personnel on Regulatory requirements.
• Support…