Regulatory Affairs Specialist Job At Illusion Dental Laboratory
The Regulatory Affairs Specialist role at Illusion Dental Laboratory offers an excellent opportunity for professionals to work on global regulatory submissions across India, the US, and the EU. This Regulatory Affairs Job position focuses on regulatory documentation, compliance, and coordination to support product registrations and audits in the medical devices and life sciences domain. Graduates seeking Pharmaceutical Science Jobs or Pharmacy Jobs can apply now.
Job Details
- Job Title: Regulatory Affairs Specialist
- Location: Mumbai, Maharashtra, India
About the Company
Illusion Dental Laboratory is a specialized organization operating in the dental and life sciences sector, focused on delivering compliant, high-quality products for global markets. The company emphasizes regulatory excellence, continuous learning, and cross-functional collaboration to meet international compliance requirements.
Educational Requirements for this Regulatory Affairs Job
- Bachelor’s or Master’s degree in Pharmaceutical Sciences
- Specialization in Regulatory Affairs or Quality Assurance preferred
Key Responsibilities for this Regulatory Affairs Job
- Conduct gap analysis of existing regulatory and technical documentation
- Prepare and maintain regulatory submissions, including Device Master Files, Risk Management Files, Design History Files, Clinical Evaluation Reports, and Usability Reports
- Draft and update product labelling such as IFUs, implant cards, and declarations
- Support regulatory submissions for India (CDSCO/SUGAM/NSWS), US (FDA), and EU (CE marking under MDR)
- Coordinate with Purchase, Accounts, Legal, Marketing, and R&D teams
- Assist with audit responses and regulatory inspections
- Support regulatory strategy for new product development and modifications
- Track regulatory updates and industry trends
Skills Required for this Regulatory Affairs Job
- Knowledge of ISO 13485, EU MDR, and 21 CFR Part 820
- Understanding of risk management, design controls, and post-market surveillance
- Strong documentation and technical writing skills
- Proficiency in Microsoft Office and digital documentation systems
- Experience with regulatory portals such as CDSCO/SUGAM/NSWS
- Exposure to global regulatory submissions
Why This Job Role?
This Regulatory Affairs Job role provides hands-on exposure to global regulatory frameworks across multiple markets, making it ideal for professionals seeking growth in medical device and life sciences regulatory affairs. It offers opportunities to work closely with cross-functional teams while building strong expertise in international compliance and documentation. Graduates seeking Pharmaceutical Science Jobs or Pharmacy Jobs can apply now.
