Advanced Microdevices Pvt. Ltd. (MDI) is a leading Indian company specializing in the design, development, and manufacturing of filtration products for pharmaceuticals, medical devices, and diagnostics. With a strong commitment to quality and innovation, MDI offers cutting-edge filtration technologies while ensuring compliance with international regulatory standards. Located in Ambala Cantonment, India, the company is looking for a Regulatory Compliance Expert / Legal Consultant to strengthen its regulatory affairs and compliance operations.
Job Responsibilities
As a Regulatory Compliance Expert / Legal Consultant – Medical Device Regulatory Specialist, the candidate will take on several key responsibilities to ensure compliance with national and international standards:
- Medical Device Registration
- Lead the registration of medical devices by coordinating with regulatory bodies.
- Ensure compliance with CDSCO (Central Drugs Standard Control Organization) guidelines and global regulatory frameworks.
- Drug Import Licensing
- Manage the preparation, submission, and follow-up of drug import license applications with relevant authorities.
- ISO 9001:2015 Compliance
- Act as the ISO 9001:2015 Management Representative, overseeing the company’s quality management systems.
- Coordinate external and internal audits, implementing improvements based on audit findings.
- CDSCO Compliance Management
- Monitor regulatory updates from CDSCO to ensure continuous compliance.
- Maintain all necessary documentation related to medical device registration and licensing.
- Agreement and Contract Management
- Draft and review supply agreements and other legal contracts to align with regulatory requirements.
- Legal Documentation and NDA Management
- Prepare, review, and manage Non-Disclosure Agreements (NDAs) to safeguard confidential business information.
How to Apply
If you meet the qualifications and are excited to be part of a leading organization, follow these steps to apply:
- Submit your resume via email to hr@mdimembrane.in.
- Subject Line: Mention the position title: Regulatory Compliance Expert/Legal Consultant – Medical Device Regulatory Specialist (MDR) / Compliance and Regulatory Affairs Operations Analyst.
