Quality Assistant Manager

Department: Quality Assurance

Reporting To: QA Manager / Head – Quality

Position Summary

The Assistant Manager – QA (Compliance & Regulatory Affairs) will be responsible for ensuring compliance with national and international regulatory requirements applicable to medical devices, overseeing quality management system effectiveness, and maintaining certifications. The role demands strong expertise in ISO 13485 and ISO 9001 standards, regulatory submissions, and internal/external audits.

Key Responsibilities

· Regulatory Compliance:
- Ensure compliance with Medical Device Rules (MDR 2017), BIS QCO requirements, and other applicable national/international regulations.- Prepare, review, and maintain technical documentation (DMF, PMF) for regulatory submissions and license renewals (e.g., MD-5 endorsements).- Monitor and implement regulatory updates impacting the company’s product portfolio.

· Quality Management System (QMS):
- Maintain and improve QMS in line with ISO 13485 and ISO 9001 requirements.- Coordinate Management Reviews, Internal Quality Audits, and CAPA follow-ups.- Oversee document control, change control, and risk management processes.

· Audits & Inspections:
- Lead and facilitate internal audits, supplier audits, and customer audits.- Prepare for and host external audits by certification bodies and regulatory authorities.- Ensure timely closure of audit findings with effective CAPA.

· Training & Awareness:
- Conduct training sessions for employees on GMP, GDP, regulatory requirements, and QMS processes.- Build awareness of compliance culture across departments.

· Product & Process Compliance:
- Review batch records, validation protocols/reports, and stability data for compliance.- Coordinate complaint handling, product recalls, and post-market surveillance activities.

Qualifications & Skills

· Bachelor’s or Master’s degree in Science, Pharmacy, Biomedical, or related discipline.

· Lead Auditor Certification in ISO 13485 and ISO 9001 (mandatory).

· Minimum 3 years’ experience in QA – Compliance & Regulatory Affairs within a medical device manufacturing company.

· Strong knowledge of Indian MDR 2017, ISO 13485, ISO 9001, BIS standards, and applicable regulatory guidelines.

· Excellent documentation, analytical, and problem-solving skills.

· Ability to manage multiple priorities in a fast-paced environment.

Key Competencies

· Attention to detail & regulatory accuracy.

· Strong communication and coordination skills.

· Proactive approach to risk assessment and compliance monitoring.

· Leadership in cross-functional team environments.

Job Type: Full-time

Pay: ₹50,000.00 - ₹60,000.00 per month

Benefits:

• Cell phone reimbursement
• Health insurance
• Paid sick time
• Provident Fund
• Work from home