Manager, Quality Assurance & Regulatory Affairs
New
A
AirStripMedical technology
Based in the United StatesFull-TimeManager
Salary100,700 - 126,000 USD per year
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Job Details
- Experience
- At least 5 years of experience managing Quality Assurance and Regulatory Affairs activities within the medical device industry; minimum 5 years of experience interpreting and applying FDA guidance, regulations, and requirements from international regulatory authorities.
- Required Skills
- Quality AssuranceRisk Management
Requirements
- Bachelor's degree in Healthcare, Information Technology, Quality Management, or a related discipline; equivalent professional experience may be considered.
- At least 5 years of experience managing Quality Assurance and Regulatory Affairs activities within the medical device industry.
- At least 5 years of experience interpreting and applying FDA guidance, regulations, and requirements from international regulatory authorities.
- Knowledge of medical device quality and regulatory frameworks, including MDSAP, MDR, UKCA, ISO 13485, and QMSR.
- Strong understanding of risk assessment, risk management methodologies, and regulatory compliance processes.
- Experience managing and continuously improving Quality Management Systems.
- Experience with CAPA, complaint handling, audits, and post-market surveillance.
- Organizational, planning, coordination, and follow-up skills, with attention to detail.
- Written and verbal communication skills and ability to collaborate across multidisciplinary teams.
- Analytical thinking and problem-solving abilities.
- Ability to coach, mentor, and support team members.
Responsibilities
- Develop, implement, and maintain Quality System Documentation to meet FDA regulations, 21 CFR Part 820, MDSAP requirements, and other applicable SaMD standards.
- Support external audits and inspections by notified bodies and regulatory authorities, maintaining audit readiness.
- Collaborate with New Product Development and Existing Product Enhancement teams across the product lifecycle.
- Contribute to Design History Files, Technical Files, Risk Management Files, Clinical Evaluation Reports, and Post-Market Surveillance documentation.
- Participate in nonconforming product and customer complaint processes, ensuring issues are documented, evaluated, investigated, and resolved.
- Lead and support CAPA initiatives to address systemic quality issues, prevent recurrence, and drive continuous improvement.
- Coordinate internal and supplier audits according to audit programs, regulations, and international quality standards.
- Monitor and analyze CAPA, complaint, clinical evaluation, and post-market surveillance data, and prepare reports for management review.
- Maintain international regulatory certifications and market authorizations, including ISO 13485:2016, MDSAP, MDD/MDR, UKCA, and CMDCAS registrations.
- Build and maintain a regulatory and compliance knowledge base and monitor regulatory changes.
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