Quality Regulatory Manager - Manufacturing (3-5 yrs)
Job Description :
- Implement a comprehensive quality management system (QMS) to ensure compliance with applicable regulations and standards, such as ISO 13485 and MDR (India) 2017 requirements.
- Manage the day-to-day operations of the quality control and quality assurance departments.
- Conduct regular inspections, audits, and assessments to monitor and evaluate the eectiveness of quality processes and procedures.
- Establish and maintain quality control documentation, including standard operating procedures (SOPs), work instructions, and quality records.
- Coordinate with cross-functional teams to ensure proper implementation of quality control measures throughout the product lifecycle, from design and development to manufacturing and distribution.
- Oversee the investigation and resolution of quality-related issues, non-conformities, and customer complaints, implementing corrective and preventive actions as necessary.
- Stay updated on relevant regulatory requirements, industry standards, and best practices to ensure compliance in all aspects of product manufacturing, labelling, and documentation.
- Prepare and submit regulatory submissions, technical files, and other documentation required for product approvals and registrations.
- Serve as the primary point of contact for regulatory agencies and notified bodies, addressing inquiries, inspections, and audits including external audits.
- Collaborate with R&D, manufacturing, and marketing teams to ensure new product development and launches comply with regulatory and quality requirements.
- Conduct training programs and provide guidance to employees on quality systems, regulatory compliance, and best practices.
- Manage the proper documentation and coordinate quality control for incoming raw material and outgoing finished goods.
- Maintain all quality related records.
Qualications & requirements :
- Bachelor's degree in a scientific or engineering discipline; advanced degree preferred.
- Minimum of 3-4 years of experience in a quality control/assurance or regulatory aairs role within the medical device or IVD industry.
- In-depth knowledge of quality management systems, regulatory requirements, and standards relevant to IVD instruments and reagents, such as ISO 13485 and MDR (India) 2017.
- Strong understanding of quality control principles, statistical analysis, and continuous improvement methodologies.
- Experience in managing regulatory submissions and interactions with regulatory agencies.
- Excellent communication skills, both verbal and written, with the ability to eectively interact with internal teams, external stakeholders, and regulatory authorities.
- Detail-oriented mindset with strong analytical and problem-solving abilities.
- Ability to lead and motivate a team, ensuring collaboration, accountability, and a culture of quality excellence.