Senior Quality Assurance and Regulatory Compliance Specialist

As a Quality and Regulatory Specialist at Fourth Frontier Technologies Private Limited, you will play a crucial role in supporting the ongoing operation and enhancement of the medical devices Quality Management System (QMS). Your passion for compliance and driving quality will be instrumental in maintaining the efficiency of the document control process and ensuring adherence to company procedures and related standards.

Key Responsibilities:

• **Quality Management System (QMS) Management:** You will be responsible for maintaining the QMS to ensure efficient document control processes and compliance with company procedures and relevant standards.
• **Compliance and Audits:** Leading QMS compliance with internal procedures and external regulations such as 21 CFR Part 820, ISO 13485, ISO 14971, MDSAP, EU MDR, and other country-specific requirements. You will also take the lead on audits and inspections by regulatory bodies, ensuring documentation readiness.
• **Corrective and Preventive Action (CAPA) and Non-Conformance (NC) Management:** Leading CAPA investigations from issue identification through resolution, including root cause analysis and effectiveness checks. Directly assisting CAPA and NC owners to ensure completeness and compliance with standards.
• **Data Analysis & Improvement:** Analyzing trends in non-conformances and CAPA data to identify systemic issues and contribute to continuous improvement initiatives. Preparing monthly metrics, maintaining logs, and sending reminders for required activities.
• **Product Lifecycle Support:** Providing quality and regulatory support throughout the medical device lifecycle, including managing documentation for Software as a Medical Device (SaMD), supporting software releases, and handling post-market activities.
• **Cybersecurity and Data Privacy Compliance:** Maintaining foundational understanding of an Information Security Management System (ISMS) and ensuring QMS and product documentation adhere to relevant security and privacy laws and regulations.
• **Cross-functional Collaboration:** Working closely with cross-functional teams to ensure a consistent and compliant approach to quality. Drafting regulated documentation and supporting quality improvement initiatives across the organization.

Qualifications Required:

• **Regulatory Knowledge:** In-depth understanding of medical device regulations including 21 CFR Part 820, ISO 13485, ISO 14971, MDSAP, and EU MDR.
• **QMS Expertise:** Hands-on experience in managing and improving a QMS, strong grasp of document control processes, and maintaining product-related quality documentation.
• **Auditing:** Experience leading audits and inspections by regulatory bodies, ability to manage deliverables, track corrective actions, and ensure timely closure.
• **CAPA/NC Management:** Direct experience leading CAPA investigations, ensuring compliance with various standards including HIPAA.
• **Data Analysis:** Robust analytical skills to analyze trends in quality data and identify systemic issues.
• **Communication:** Excellent communication and collaboration skills to work effectively with various teams and external parties.

Your background should include:

• Bachelor's degree in a relevant field (e.g., Engineering, Life Sciences).
• Minimum of 3-5 years of experience in a Quality or Regulatory role within the medical device industry.
• Prior experience with EU MDR is required.
• Demonstrated experience managing and drafting regulated documentation.
• Experience with pre-market and post-market activities for medical devices.
• Basic understanding of medical device production activities.

Desirable Criteria:

• Professional certifications such as ISO 13485 and MDSAP Internal Auditor, ASQ (American Society for Quality) are a plus. As a Quality and Regulatory Specialist at Fourth Frontier Technologies Private Limited, you will play a crucial role in supporting the ongoing operation and enhancement of the medical devices Quality Management System (QMS). Your passion for compliance and driving quality will be instrumental in maintaining the efficiency of the document control process and ensuring adherence to company procedures and related standards.

Key Responsibilities:

• **Quality Management System (QMS) Management:** You will be responsible for maintaining the QMS to ensure efficient document control processes and compliance with company procedures and relevant standards.
• **Compliance and Audits:** Leading QMS compliance with internal procedures and external regulations such as 21 CFR Part 820, ISO 13485, ISO 14971, MDSAP, EU MDR, and other country-specific requirements. You will also take the lead on audits and inspections by regulatory bodies, ensuring documentation readiness.
• **Corrective and Preventive Action (CAPA) and Non-Conformance (NC) Management:** Leading CAPA investigations from issue identification through resolution, including root cause analysis and effectivenes