Manager - Regulatory Affairs

Company Description

Sysmed Exim Private Limited, established in 2014, is India's Pioneering Healthcare Facilitator and Equipment Aggregator Company based in Chandigarh. The company's mission is to make healthcare services more accessible and affordable worldwide through innovative thinking and world-class health services.

Role Description

This is a full-time on-site role for Manager - Regulatory Affairs at Sysmed Medical Technologies ( sister concern of Sysmed Exim Private Limited ) headquartered at Chandigarh and having manufacturing plant at Nabha Punjab under make in India project. The Quality Head will be responsible for quality engineering, quality control, quality assurance, product quality, and quality management tasks on a day-to-day basis.

Requirements

• Minimum of 5 years of experience in quality assurance, preferably in the medical devices manufacturing industry.
• Expert knowledge of quality management systems and regulatory requirements (ISO 13485, FDA regulations).
• Strong leadership and managerial skills.
• Excellent problem-solving and decision-making abilities
• Effective communication and interpersonal skills. Attention to detail and strong analytical skills
• Ability to work well in a cross-functional team environment.
• Roles and Responsibilities
• Develop and implement quality assurance policies and procedures for the medical devices manufacturing department.
• Manage and oversee the quality control inspections and testing processes.
• Ensure compliance with regulatory requirements and industry standards.
• Optimize manufacturing processes to enhance efficiency and minimize defects.
• Conduct internal and external audits to assess compliance and identify areas for improvement.
• Train and mentor staff on quality assurance techniques and best practices.
• Monitor and analyze quality metrics to drive continuous improvement.
• Prepare and present reports on quality performance to senior management
• Quality Engineering, Quality Control, and Quality Assurance skills
• Product Quality and Quality Management expertise.
• Experience in implementing quality processes and standards
• Knowledge of quality assurance principles and methodologies

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• Salary

- Hike on current salary.

Job Types: Full-time, Permanent

Pay: Up to ₹85,000.00 per month

Benefits:

• Health insurance
• Paid time off

Work Location: In person