Sr. Director – Quality Assurance & Regulatory Affairs
Moximed, Fremont, California, us, 94537
The Senior Director of Quality Assurance and Regulatory Affairs is a critical member of the leadership team, responsible for establishing and leading the company’s quality and regulatory function, as well as championing Moximed’s total quality management system for orthopedic implants and single-use instruments.
Quality Assurance and Regulatory Affairs
Fremont - Hybrid
Sr. Director - Quality Assurance & Regulatory Affairs
This leader oversees all aspects of quality assurance, quality control, regulatory affairs, compliance, and post-market surveillance. They will also guide the regulatory strategy needed to support current commercial products and future pipeline innovations in conjunction with senior management.
The Senior Director will define organizational structure, hire key roles, and foster talent development within the QA and RA department to help ensure successful completion of projects and company milestones in close collaboration with Research and Development, Operations, Sales, Marketing and Clinical Affairs.
This role includes being the Regulatory Affairs team representative for interactions with regulatory bodies, primarily the US FDA and, as such, will oversee activities related to submissions, registrations and listings, and Medical Device Reporting in cooperation with multiple departments.
What You’ll Do Quality 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.
Regulatory Affairs
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 clinicaltrials.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 the Complaint Handling Unit, particularly with timely regulatory assessments of complaints for reportability determination for any adverse event or malfunction.
About You
Bachelor’s or advanced degree preferred in Life Sciences, engineering or other technical discipline or other equivalent job experience.
15+ years of progressive experience in medical device quality assurance and/or regulatory affairs roles. Prior orthopedic medical device experience or experience with Class II/III implantable devices is a plus.
Minimum of 12 years of progressive managerial experience successfully managing technical personnel and complex activities as required.
Demonstrated strong leadership presence with ability to collaborate cross-functionally and build high-performing teams.
Excellent working knowledge of FDA and international regulatory requirements and standards required. Experience with preparing international submissions/registrations required.
Organize and lead teams and sub-teams to address complex quality and regulatory strategies in a growth-stage environment.
Demonstrates strong organizational skills and the ability to collect and assess data, establish facts and report on findings.
Demonstrates the highest levels of integrity, and good interpersonal and presentation skills.
Have a working knowledge of ISO13485, 21 CFR820, preferred knowledge of MDR.
Possess leadership qualities and be a great team player; possess the ability to communicate clearly and effectively, both orally and in writing; demonstrate capacity to calmly, clearly and consistently communicate regulations to technical functions within the company; possess the ability to handle multiple tasks, and the ability to think strategically while attending appropriately to details.
Must be able to read, analyze, interpret and assist in the creation and refinement of company procedures; demonstrate the ability to define problems, collect data, establish facts, draw valid conclusions and report on findings. The candidate must be able to demonstrate the highest level of integrity, excellent negotiation skills, and excellent interpersonal and presentation skills.
Strong work ethic.
#J-18808-Ljbffr
Quality Assurance and Regulatory Affairs
Fremont - Hybrid
Sr. Director - Quality Assurance & Regulatory Affairs
This leader oversees all aspects of quality assurance, quality control, regulatory affairs, compliance, and post-market surveillance. They will also guide the regulatory strategy needed to support current commercial products and future pipeline innovations in conjunction with senior management.
The Senior Director will define organizational structure, hire key roles, and foster talent development within the QA and RA department to help ensure successful completion of projects and company milestones in close collaboration with Research and Development, Operations, Sales, Marketing and Clinical Affairs.
This role includes being the Regulatory Affairs team representative for interactions with regulatory bodies, primarily the US FDA and, as such, will oversee activities related to submissions, registrations and listings, and Medical Device Reporting in cooperation with multiple departments.
What You’ll Do Quality 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.
Regulatory Affairs
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 clinicaltrials.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 the Complaint Handling Unit, particularly with timely regulatory assessments of complaints for reportability determination for any adverse event or malfunction.
About You
Bachelor’s or advanced degree preferred in Life Sciences, engineering or other technical discipline or other equivalent job experience.
15+ years of progressive experience in medical device quality assurance and/or regulatory affairs roles. Prior orthopedic medical device experience or experience with Class II/III implantable devices is a plus.
Minimum of 12 years of progressive managerial experience successfully managing technical personnel and complex activities as required.
Demonstrated strong leadership presence with ability to collaborate cross-functionally and build high-performing teams.
Excellent working knowledge of FDA and international regulatory requirements and standards required. Experience with preparing international submissions/registrations required.
Organize and lead teams and sub-teams to address complex quality and regulatory strategies in a growth-stage environment.
Demonstrates strong organizational skills and the ability to collect and assess data, establish facts and report on findings.
Demonstrates the highest levels of integrity, and good interpersonal and presentation skills.
Have a working knowledge of ISO13485, 21 CFR820, preferred knowledge of MDR.
Possess leadership qualities and be a great team player; possess the ability to communicate clearly and effectively, both orally and in writing; demonstrate capacity to calmly, clearly and consistently communicate regulations to technical functions within the company; possess the ability to handle multiple tasks, and the ability to think strategically while attending appropriately to details.
Must be able to read, analyze, interpret and assist in the creation and refinement of company procedures; demonstrate the ability to define problems, collect data, establish facts, draw valid conclusions and report on findings. The candidate must be able to demonstrate the highest level of integrity, excellent negotiation skills, and excellent interpersonal and presentation skills.
Strong work ethic.
#J-18808-Ljbffr