Regulatory Affairs Specialist

Job Title: Regulatory Affairs Specialist

Location: Devine Meditech, Okhla phase -1, New Delhi
Experience Required: 3–5 Years
Industry: Medical Devices / Healthcare / Surgical Equipment
Salary Range: ₹30,000 – ₹50,000 per month (negotiable based on skills and experience)
Reporting to: Head – Quality & Regulatory Affairs

Job Summary:

Devine Meditech is seeking a dynamic and detail-oriented Regulatory Affairs Specialist with 3–5 years of experience in the medical devices industry. The role involves ensuring product compliance with Indian and international regulatory requirements, preparing regulatory submissions, and maintaining up-to-date product documentation in line with applicable standards (e.g., MDR, CE, ISO 13485).

Key Responsibilities:

• Prepare and submit dossiers for regulatory approvals (CDSCO, CE Mark, US FDA if applicable).
• Review and compile Technical Files, Product Master Files (PMFs), and Device Master Records (DMRs).
• Manage regulatory submissions for new products and changes to existing products.
• Liaise with government authorities (CDSCO, State FDA, BIS) for licensing, renewals, and product registrations.
• Ensure compliance with ISO 13485, MDR 2017, and other international regulatory requirements.
• Monitor changes in regulatory requirements and communicate updates to relevant teams.
• Support internal and external audits (Notified Bodies, CDSCO inspections).
• Prepare and maintain documentation for QMS, labeling, IFUs, and risk assessments.
• Collaborate with R&D, QA, and production teams during product development for regulatory compliance.
• Assist in Post-Market Surveillance and vigilance reporting.

Desired Candidate Profile:

• Education: Bachelor’s or Master’s in Life Sciences / Pharmacy / Biomedical Engineering / Regulatory Affairs.
• Experience: 3–5 years in regulatory affairs in a medical devices or healthcare manufacturing setup.
• Knowledge of: MDR 2017, CE marking, ISO 13485, BIS, and CDSCO regulatory framework.
• Strong communication and documentation skills.
• Attention to detail and ability to manage multiple projects.
• Familiar with product classification, risk assessment, and international standards.

Preferred Certifications (if any):

• RAC (Regulatory Affairs Certification)
• Training in ISO 13485 or EU MDR
• QMS Lead Auditor (optional)

Why Join Devine Meditech?

• Work with a fast-growing leader in ophthalmic and surgical medical devices.
• Opportunity to contribute to global compliance and product registrations.
• Collaborative and innovative work environment.

Job Type: Full-time

Pay: ₹20,348.59 - ₹50,136.16 per month

Benefits:

• Paid sick time

Work Location: In person