Posted:3 days ago|
Platform:
On-site
Full Time
Job Description for the Role of Team Lead - Compliance
Job Title: Team Leader – Compliance
Department: Compliance
Location: Ambernath,
Experience Required: 7+ Years
Job Summary: The Lead – Regulatory Compliance is responsible for ensuring that the organization’s electronic medical and industrial devices comply with applicable domestic and international regulatory requirements. This role demands strategic oversight of regulatory submissions, audits, training, and quality system management, including US FDA, ISO 9001:2015, ISO 13485:2016, MDR 2017/745, MDR (India) and MDSAP. The position acts as a key liaison between regulatory authorities and internal departments, promoting a culture of compliance and continuous improvement.
Key Responsibilities:
1. Regulatory Strategy & Compliance
2. Product Lifecycle & Documentation
3.Quality Management System (QMS) Oversight
4. Training & Competency Management
5. Stakeholder Collaboration
6. Risk Management
7. Clinical Evaluation
8. Regulatory Audits & Inspections
9. Continuous Improvement & Risk Management
10. Confidentiality & Integrity
Qualifications & Skills:
Job Type: Full-time
Pay: ₹400,000.00 - ₹1,204,891.35 per year
Benefits:
Ability to commute/relocate:
Experience:
Work Location: In person
Alan Electronic systems Pvt. Ltd.
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Amarnath, Maharashtra
4.0 - 12.04891 Lacs P.A.