Illusion Dental Laboratory Hiring For Regulatory Affairs Specialist

Illusion Dental Laboratory is hiring a Regulatory Affairs Specialist in Andheri West, Mumbai. This on-site, full-time role is ideal for regulatory professionals with 1–4 years of experience in medical devices or life sciences, offering hands-on exposure to India CDSCO, US FDA, and EU MDR (CE marking) submissions.

If you are looking to build or strengthen your career in medical device regulatory affairs, this opportunity provides end-to-end involvement in technical documentation, audits, and global compliance activities.

📌 Job Overview

• Position: Regulatory Affairs Specialist
• Industry: Medical Devices / Dental Devices
• Company: Illusion Dental Laboratory
• Location: Andheri West, Mumbai, Maharashtra
• Experience: 1–4 years
• Employment Type: Full-time, On-site
• Working Days: Monday to Saturday
• Vacancies: 1

🧾 Key Responsibilities

As a Regulatory Affairs Specialist, you will be responsible for:

• Conducting gap analysis of regulatory and technical documentation
• Preparing and maintaining:
  • Device Master Files (DMF)
  • Risk Management Files (ISO 14971)
  • Design History Files (DHF)
  • Clinical Evaluation Reports (CER)
  • Usability Engineering Reports
• Drafting and updating product labeling including IFUs, implant cards, and declarations
• Supporting regulatory submissions for:
  • India: CDSCO, SUGAM, NSWS
  • United States: US FDA (21 CFR Part 820)
  • Europe: EU MDR / CE Marking
• Coordinating with R&D, Purchase, Accounts, Legal, and Marketing teams
• Assisting in regulatory audits, inspections, and query responses
• Supporting regulatory strategy for new product development and design changes
• Staying updated with global regulatory guidelines and industry trends

🎓 Educational Qualifications

• Bachelor’s or Master’s degree in:
  • Pharmaceutical Sciences
  • Biotechnology
  • Microbiology
  • Engineering
  • Life Sciences or related fields
• Regulatory Affairs or Quality Assurance specialization preferred

🧪 Experience Requirements

• 1–4 years of experience in Regulatory Affairs
• Experience in medical devices, dental devices, pharmaceuticals, or life sciences
• Hands-on exposure to global regulatory submissions
• Working knowledge of CDSCO / SUGAM / NSWS portals (mandatory)
• Knowledge of software regulations is an added advantage

🛠️ Key Skills & Competencies

• Strong understanding of:
  • ISO 13485
  • EU MDR
  • US FDA 21 CFR Part 820
  • Risk management & design controls
• Excellent technical writing and documentation skills
• Proficiency in Microsoft Office and digital documentation systems
• Strong coordination and stakeholder management skills
• High English proficiency (written and verbal)

🌟 Why Join Illusion Dental Laboratory?

• Exposure to global medical device regulations (India, US & EU)
• Opportunity to work on complete regulatory lifecycle activities
• Fast-growing dental and medical device environment
• Skill development in EU MDR and US FDA compliance
• Strong career growth for early to mid-level regulatory professionals

📨 How to Apply

Application Link