QA/regulatory Affairs

3 days ago

Kochi Kerala, India MI Devices Pvt Ltd Full time

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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