SUMMARY:

The Manager of Quality Assurance and Regulatory Affairs ensures continued regulatory conformity to FDA 21CFR820, ISO13485, ISO14971, and EU Medical Device Regulation (EUMDR).  This position reports to the US CEO and indirectly to the Group Director of Quality Management and Regulatory Affairs.

This role encompasses a wide range of responsibilities, including the development and implementation of quality system procedures, training associates on updated procedures, overseeing the Corrective and Preventive Action process (CAPA), evaluating product and process non-conformances, and providing support to production and inspection teams in addressing quality-related challenges.

The manager demonstrates excellence in cross-functional collaboration and effectively collaborates with teams at all organizational levels. Together, we are committed to upholding the highest standards of product quality and regulatory compliance.

RESPONSIBILITIES:

• General Responsible for compliance of Quality System regarding ISO Standard 13485 alignment with Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP), FDA and other applicable requirements, laws and standards.
• In coordination with Group Regulatory leadership, ensure the management of the Regulatory Affairs Processes, Registration, Non-Conformities, Product Recalls and Medical Device Reporting (EUMDR) for HSU. Act as Person Responsible for Regulatory Compliance (PRRC).
• Maintain an effective quality management system (QMS) to ensure the consistent delivery of high-quality products.
• Define and monitor key quality performance metrics, ensuring continuous improvement in product quality.
• In charge of HIPAA-related activities, including Privacy Officer training for associates on updated and enhanced quality system procedures and instructions
• Overseeing Vigilance and Post-Market Surveillance activities
• Leads and guides the quality and regulatory team, offering coaching to the purchasing staff and fostering collaboration between inspection personnel and other departments.
• Manages staff selection, performance, development, and training to ensure team competencies align with business goals.
• Identifies department training needs and develops materials to support company objectives.
• Responsible for the quality interests and concerns of projects – assisting design controls (Design Inputs/Outputs, Design Verification and Validation, Design and Process Risk Management – DFMEA/PFMEA, Design Master Record, Design History Files, etc.)
• Expertise in validation, verification, and usability processes for new and improved products.
• Lead the CAPA process ensuring timely and effective resolution. 
• Responsible for the System Computer Software Validation in compliance of the standards and regulations.
• Establishes and maintains the Company System Procedures for regulatory compliance.
• Manages incident reporting and adverse event recalls.
• In coordination with Group Regulatory leadership, ensure Establishment Registration & Device Listing of class I and II Medical Devices for HSU.
• Oversees Risk Management for Medical Devices according to ISO 14971
• Promotes the development of Quality Competencies and Quality Awareness throughout the organization.

KNOWLEDGE, SKILLS, AND ABILITIES:

• Bachelor's degree in a relevant field or Engineering; advanced degree preferred with greater than 8 years of experience in the creation and Management of Quality Systems.
• Related experience in Medical Device FDA-regulated industry to include product/process validation and solving technical problems preferred.
• Experience working as a Quality Engineer or Manager in a manufacturing environment Competent in FDA QSR, ISO 13485, and ISO9001, ISO14971, & EUMDR requirements.
• Knowledge of FDA regulations and international regulatory requirements.
• Excellent leadership and team management skills.
• Strong analytical and problem-solving abilities.
• Demonstrated ability to work collaboratively across departments.
• Skilled auditor with knowledge of FDA, ISO13485, and EUMDR requirements. 
• Ability to read and interpret drawings and design specifications.
• Proficient in technical writing skills and communications.