Director Regulatory Affairs & Quality Medical Device

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Position Summary: The Director RA/QA is responsible for building, advancing, and sustaining the Quality Management System (QMS) and ensuring that it meets applicable state, federal, and international regulations and business quality standards. Additionally, this role is responsible for establishing a regulatory strategy and maintaining compliance with applicable regulatory requirements. The Director RA/QA will be supported by consulting Subject Matter Experts (SME) for both Regulatory Affairs and Quality Assurance.

Responsibilities:

• Lead maintenance and advancement of the company QMS including sustaining its certification to ISO 13485.
• Establish and maintain compliance with Class I/II medical device regulatory requirements for the US and Canada through Regulatory strategy and ongoing reviews of product and regulatory guidance changes.
• Establish and maintain compliance with Data Privacy and Security regulatory requirements.
• Serve as the Organization’s Management Representative (MR), the point of contact for all quality and regulatory communication with applicable agencies and bodies.
• Process owner for all QMS processes.
• Responsible for working with Engineering and Operations to advance the Design Control systems and develop validation/qualification protocols and Risk Management files that meet applicable Regulations, Guidance, and Procedures.
• Conduct internal audits and coordinate and manage external ISO/Regulatory audit schedules, correspondence, and closing of findings.
• Effective and timely review of change orders and technical documentation.
• Review, audit, and approve Device Master Records, Design History Files, and ensure that the records and files are updated.
• Responsible for managing RA/QA department, including internal and external resources and partners.
• Responsible for reviewing and establishing the company quality goals and objectives each year and leading Management Reviews.
• Establish and maintain Key Process Indicators.

Requirements:

• BS in Engineering, Regulatory Affairs, Quality Engineering, or equivalent technical degree.
• 5+ years of medical device management experience.
• Demonstrated aptitude in leading teams and organizations that comply with 21 CFR 200 et al, 21 CFR 820, 21 CFR 830, SOR/98-282, and ISO13485.
• Regulatory compliance related to medical device industry, including experience submitting medical device applications for US and Canada.
• Knowledge of Data Privacy and Security Regulations and Standards.
• Proven experience working directly with domestic and foreign regulatory authorities.
• Ability to analyze and interpret standards and government guidance and regulation documents and translate into internal strategies and policies.
• Ability to write standard operating procedures, work instructions, specifications, and technical reports.
• Ability to effectively communicate company status, goals, and initiatives throughout the organization.
• Demonstrated success in leading teams and departments, including external partners.
• Ability to effectively communicate company status, goals, and initiatives throughout the organization.
• A hands-on leader willing to work side by side with a small, agile team.
• Certified Quality Auditor (CQA) – Regulatory Affairs Certification (RAC) – Six Sigma Certification -Experience with Veeva Software preferred.
• Experience with all applications in Microsoft Office 365.

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