About the Role:
We are seeking a skilled Regulatory Compliance Expert with a focus on medical device registration, drug import licensing, and regulatory compliance to join our team. This individual will be responsible for ensuring adherence to industry standards and legal regulations for medical devices, drugs, and management systems. The role requires a proactive professional experienced in ISO 9001:2015, CDSCO (Central Drugs Standard Control Organization) compliance, supply agreements, and drafting legal documents including NDA’s.
Key Responsibilities:
- Medical Device Registration: Lead and manage the registration process for medical devices, ensuring compliance with all applicable national and international regulatory standards.
- Drug Import Licensing: Handle all aspects of the drug import licensing process, including the preparation, submission, and management of applications to regulatory authorities.
- ISO 9001:2015 Compliance: Act as the ISO 9001:2015 Management Representative, overseeing quality management systems, coordinating audits, and implementing continual improvement measures.
- Compliance and Application with CDSCO: Monitor and ensure compliance with CDSCO guidelines, policies, and procedures, maintaining updated knowledge of any changes in requirements.
- Agreement/Contract Management: Draft, review supply agreements and other business contracts to ensure compliance with legal and regulatory requirements.
- Legal Documentation and NDA Management: Prepare and review legal documents, including non-disclosure agreements (NDAs), to protect company interests and maintain compliance with confidentiality standards.
Preferred Qualifications and Skills:
- Educational Background: Bachelor’s or Master’s degree in Business Law, Regulatory Affairs, Bachelor’s /Master’s in Engineering or a related field.
- Professional Experience: Candidates with Experience or Freshers who possess strong reading and comprehension skills in regulatory compliance, particularly in the medical device, pharmaceuticals, or healthcare sector.
- Regulatory Knowledge: In-depth understanding of CDSCO regulations, ISO 9001:2015 standards, and other applicable regulatory frameworks.
- Communication: Excellent written and verbal communication skills with a strong ability to explain complex regulatory requirements to cross-functional teams.
- Detail-Oriented: Highly organized with a keen eye for detail and a proactive approach to managing compliance challenges.
Compensation and Benefits: Competitive salary commensurate with experience and qualifications. (No constraint for deserving candidate)
How to Apply:
If you meet the qualifications and are excited about the opportunity to join our team, please submit your resume to hr@mdimembrane.in, please mention the position Job Title: Regulatory Compliance Expert/Legal Consultant–Medical Device Regulatory Specialist (MDR) /Compliance and Regulatory Affairs Operations Analyst in subject line.
*Candidates who are natives of Ambala or natives within a radius of 30km need to apply only
MDI is an equal opportunity employer and welcomes applications from individuals of all backgrounds.