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Director of Quality
4 months ago
**Director of Quality and Regulatory Affairs (Medical Devices)**
**Position Overview:**
As the Director of Quality and Regulatory Affairs in the medical device industry, you will be responsible for ensuring compliance with regulatory requirements, maintaining high-quality standards, and driving continuous improvement initiatives. You will lead a team in developing and implementing quality management systems while interfacing with regulatory agencies to secure approvals for new products and maintain existing ones.
**Key Responsibilities:**
- **Regulatory Compliance:** Oversee all aspects of regulatory compliance for medical device products, ensuring adherence to FDA regulations, ISO standards, and other applicable requirements.
- **Quality Management Systems (QMS):** Develop, implement, and maintain QMS processes and procedures to ensure product quality and compliance throughout the product lifecycle.
- **Regulatory Strategy:** Develop and execute regulatory strategies for new product development, submissions, and approvals, including pre-market approvals (PMAs), 510(k) submissions, and CE marking.
- **Audits and Inspections:** Coordinate and manage regulatory audits and inspections, preparing and guiding the organization through regulatory agency inspections and audits.
- **Risk Management:** Lead risk management activities, including risk assessment, mitigation, and monitoring, to ensure patient safety and product efficacy.
- **Cross-Functional Collaboration:** Collaborate with R&D, manufacturing, marketing, and other departments to ensure regulatory and quality requirements are integrated into product development and commercialization processes.
- **Training and Development:** Provide leadership and guidance to the quality and regulatory team, ensuring adequate training and development to maintain a high level of expertise.
- **Complaint Handling and CAPA:** Oversee complaint handling processes, including investigation, root cause analysis, and implementation of corrective and preventive actions (CAPAs) to address quality issues.
- **Post-Market Surveillance:** Establish and maintain post-market surveillance systems to monitor product performance, analyze trends, and implement necessary actions to address safety and efficacy concerns.
- **Documentation and Reporting:** Ensure accurate and timely documentation of quality and regulatory activities, including regulatory submissions, technical files, and regulatory correspondence.
**Qualifications:**
- Bachelor's degree in a relevant scientific or engineering discipline; advanced degree preferred.
- Minimum of 7-10 years of experience in quality assurance and regulatory affairs in the medical device industry.
- In-depth knowledge of FDA regulations, ISO standards, and other global regulatory requirements for medical devices.
- Proven experience leading regulatory submissions, including PMAs, 510(k)s, and CE marking applications.
- Strong leadership and communication skills, with the ability to influence and collaborate across functional teams.
- Experience managing regulatory audits and inspections by FDA and other regulatory agencies.
- Knowledge of quality management principles, including risk management, CAPA, and post-market surveillance.
- Certification in Regulatory Affairs (RAC) or Quality Management (e.g., ASQ certifications) is desirable.
- Ability to thrive in a fast-paced, dynamic environment and drive continuous improvement initiatives to enhance product quality and regulatory compliance.
Apply Director or email klelix.hamlin@lumicity.io
