QA/regulatory Affairs
3 days ago
Our company is establishing a new state-of-the-art medical device manufacturing facility and is seeking a highly motivated and experienced **QA/Regulatory Affairs Specialist** to lead documentation, compliance, and licensing activities. We are committed to innovation, patient safety, and excellence in regulatory standards.
**Job Summary**:
**Key Responsibilities**:
- Develop, implement, and maintain the Quality Management System (QMS) in accordance with ISO 13485 and other relevant standards.
- Prepare and manage regulatory submissions for medical devices
- Oversee facility licensing and product registration for new manufacturing operations.
- Ensure documentation compliance including SOPs, DHRs, DHFs, CAPAs, and audits.
- Serve as the primary liaison with regulatory authorities and notified bodies.
- Support internal and external audits, inspections, and certifications.
- Collaborate with cross-functional teams (engineering, production, R&D) to ensure regulatory compliance throughout the product lifecycle.
**Qualifications**:
- Bachelor’s degree in Engineering, Life Sciences, Regulatory Affairs, or a related field.
- Minimum of 2-5 years of experience in QA/RA roles in the **medical device industry**.
- Proven experience with device documentation and licensing for manufacturing facilities.
- In-depth knowledge of regulatory requirements (ISO 13485, EU MDR).
- Strong analytical, organizational, and communication skills.
**Preferred**:
- RAC certification or similar credential.
- Experience setting up QA/RA systems for new manufacturing sites.
**What We Offer**:
- Competitive salary and benefits package.
- Opportunity to be part of a growing team and make a meaningful impact.
- Supportive and innovative work environment.
Pay: ₹20,000.00 - ₹35,000.00 per month
**Benefits**:
- Cell phone reimbursement
- Health insurance
Schedule:
- Day shift
Supplemental Pay:
- Performance bonus
Work Location: In person
Application Deadline: 15/05/2025
Expected Start Date: 01/06/2025
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