Overview
Quality Assurance Specialist Jobs in Madison, WI at MilliporeSigma
Job Title: QA/RA Manager (Quality Assurance and Regulatory Affairs Manager) – IVD
Position Overview:
The QA/RA Manager for IVD is responsible for ensuring that all in vitro diagnostic products meet the necessary quality standards and regulatory requirements throughout their lifecycle. This includes overseeing the development and implementation of Quality Management Systems (QMS) and managing regulatory submissions to agencies like the FDA, CE, or other regional health authorities. The role requires a deep understanding of both IVD-specific quality systems and the regulatory landscape for diagnostics.
Key Responsibilities:
Quality Assurance:
Develop, implement, and maintain a Quality Management System (QMS) tailored to IVD products, ensuring compliance with ISO 13485, 21 CFR 820 (FDA), EU IVDR, and other relevant standards.
Lead internal and external audits (ISO, FDA, CE, etc.), ensuring corrective and preventive actions are taken to address non-conformities.
Ensure that all in vitro diagnostic products meet applicable quality standards, including the management of product development, manufacturing processes, and validation activities.
Oversee the review and approval of product design and development documents, including design history files (DHFs), risk assessments (ISO 14971), and traceability matrices.
Ensure accurate and compliant product labeling, instructions for use (IFU), and technical documentation.
Manage complaint handling, product recalls, and CAPA (Corrective and Preventive Action) systems in alignment with regulatory requirements.
Regulatory Affairs:
Provide regulatory strategy advice to internal stakeholders regarding market entry, labeling, and clinical trials for new and existing products.
Ensure that IVD products’ labeling and promotional materials comply with relevant regulations, including the proper claims and disclaimers.
Ensure the maintenance of technical documentation and the completion of regulatory filings, ensuring compliance with regional and international requirements.
Serve as the primary point of contact for regulatory authorities and manage communications during inspections, audits, and product registrations.
Monitor and interpret changes in regulatory requirements (e.g., FDA, EU IVDR, CLIA) to ensure continued compliance.
Oversee regulatory submissions for IVD products, including premarket notifications (510(k)), CE mark certifications, and other regional filings (e.g., TGA, Health Canada, etc.).
Cross-functional Collaboration:
Facilitate training programs for employees on regulatory and quality standards and ensure ongoing compliance awareness.
Provide regulatory input during product development and change management processes, ensuring that all changes are adequately evaluated from a regulatory perspective.
Ensure compliance with risk management processes for IVD products, including conducting hazard analyses, risk assessments, and mitigation strategies.
Support the development of clinical evaluation plans and reports as required by regulatory bodies (e.g., Clinical Trial Applications, Clinical Investigations).
Collaborate closely with R&D, manufacturing, and operations teams to ensure the integration of quality and regulatory requirements into product design, manufacturing, and distribution processes.
Qualifications:
Bachelor’s degree in Life Sciences, Biomedical Engineering, or a related field (Master’s or MBA preferred).
Minimum of 5 years of experience in Quality Assurance and Regulatory Affairs within the IVD or medical device industry.
In-depth knowledge of IVD-specific regulatory requirements, such as the EU In Vitro Diagnostic Regulation (IVDR), FDA 21 CFR Part 820, ISO 13485, and CLIA.
Experience with regulatory submissions, including 510(k), CE Mark, and other relevant IVD certifications.
Strong understanding of the IVD product lifecycle, from development to post-market surveillance.
Familiarity with risk management standards (e.g., ISO 14971) and the clinical validation of IVDs.
Experience with electronic quality management systems (eQMS) and document control tools.
Certification in Regulatory Affairs (e.g., RAC) or Quality Management (e.g., Six Sigma, ASQ Certified Quality Manager) is a plus.
Preferred Skills:
Experience with clinical trials and clinical evaluations for IVDs.
Knowledge of global IVD regulations, including those in emerging markets (e.g., China, India).
Familiarity with software as a medical device (SaMD) and related regulations.
Strong problem-solving and critical-thinking abilities.
Ability to work cross-functionally and effectively communicate across teams and with regulatory authorities.
Working Environment:
Ability to manage multiple projects simultaneously and thrive in a fast-paced and dynamic environment.
Title: Quality Assurance Specialist
Company: MilliporeSigma
Location: Madison, WI
