Regulatory Affairs Executive (Medical devices)

Job Title: Regulatory Executive- Medical Devices
Salary: ₹3,60,000 – ₹6,00,000 per annum
Location: Noida Sec-63
Experience: Minimum 2 years

Job Description:

We are seeking a dedicated Regulatory Executive for our medical device company to manage and coordinate all regulatory and licensing activities. The candidate will be responsible for preparing and maintaining regulatory documents, ensuring compliance with medical device regulations, obtaining mandatory certifications, and liaising with regulatory authorities.

Key Responsibilities:

• Handling all licensing and regulatory work related to medical devices, including application, renewal, modification, and compliance.
• Preparing, reviewing, and maintaining regulatory documents such as device registration files, certificates, dossiers, and submissions.
• Coordinating with regulatory bodies such as CDSCO, State FDA, BIS, GST, IEC, MSME, Pollution Control Board, etc.
• Preparing and submitting applications for Form MD-5/MD-9/MD-10, import licenses, wholesale licenses, and manufacturing-related approvals (as applicable).
• Monitoring changes in medical device regulations and ensuring timely compliance with CDSCO guidelines and Medical Device Rules (MDR-2017).
• Maintaining updated records of approvals, certificates, agreements, calibration reports, and statutory documentation.
• Following up with authorities, notified bodies, consultants, and stakeholders for timely approvals.
• Supporting audits, inspections, and compliance activities such as QMS (ISO 13485) documentation.
• Assisting in preparation of SOPs, compliance checklists, and regulatory guidelines.
• Ensuring accurate regulatory communication and timely submissions as required by authorities.

Required Skills & Qualifications:

• Graduate/Postgraduate in Science, Biomedical Engineering & related field.
• At least 2 years of regulatory experience in the medical device.
• Good knowledge of Medical Device Rules (MDR-2017), CDSCO processes, and licensing work.
• Strong understanding of documentation and compliance requirements for medical devices.
• Good communication and coordination skills.
• Proficiency in MS Office, online government portals, and regulatory submission platforms.
• Strong attention to detail and ability to manage multiple tasks efficiently.

Job Type: Full-time

Pay: ₹30,000.00 - ₹50,000.00 per month

Application Question(s):

• Current salary
• Expected salary

Experience:

• toatl: 5 years (Preferred)

Work Location: In person