Manager, Quality Assurance & Regulatory

Tecomet-posted 4 months ago

Mid Level

Manchester, NH

Miscellaneous Manufacturing

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The Quality Assurance & Regulatory Affairs Manager oversees the quality management system (QMS) and ensures compliance with 21 CFR § Part 820, ISO 13485, ISO 14971, AS9100, and applicable regulatory standards. This role manages Quality Engineering and Inspection teams, leads audits, coordinates corrective and preventive actions, and collaborates cross-functionally to ensure all products meet Tecomet's quality standards and regulatory requirements. The role is critical in maintaining Tecomet's quality reputation, ensuring regulatory compliance, driving process improvements, reducing compliance costs, and ensuring the safety and effectiveness of every product.

Develop and maintain strong relationships with regulatory agencies, customers, and other stakeholders.
Coach and provide training for Quality Engineers and Inspectors while projecting a positive and professional image of the company and management to employees at all levels.
Ensure compliance with applicable regulatory requirements, including submission of necessary documentation to regulatory bodies.
Assure consistent controls in the manufacturing process for continuous quality improvement and the reduction of quality and compliance costs.
Measure the effectiveness of the systems and compliance programs in place, report findings to upper management, and develop corrective action plans.
Coordinate internal and external audits (customer, supplier, regulatory, third-party) to assess compliance and identify areas for improvement.
Review and approve documentation such as SOPs, work instructions, validation protocols, and regulatory submissions for accuracy, completeness, and compliance.
Develop and implement Corrective and Preventive Actions (CAPA) to address nonconformances, trends, and regulatory issues by managing CAPA systems and driving continuous improvements.
Stay current with evolving regulations and standards to ensure that company practices remain compliant.
Oversee supplier qualification, audits, performance monitoring, and regulatory compliance of supply chain partners.
Lead and support regulatory submissions, certifications, and registration activities as required.
Monitor changes in regulations and standards to guide company policies and practices accordingly.

Bachelor's degree in Engineering, Life Sciences, Regulatory Affairs, or a related field, or equivalent work experience in the medical device industry.
5+ years of experience in quality assurance and regulatory affairs within a regulated industry (medical devices preferred).
Comprehensive understanding of FDA regulations, ISO 13485, ISO 14971, and other relevant standards.
Knowledge of regulatory submission processes and documentation requirements.
Strong analytical skills with the ability to identify issues and implement solutions.
Excellent written and verbal communication skills, including regulatory reporting and documentation.
Proficiency with Microsoft Office suite and data analysis tools.
Familiarity with quality management and regulatory software (e.g., CAPA systems, regulatory tracking tools).
Attention to detail and a strong commitment to regulatory compliance and high-quality standards.

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