Regulatory Affairs Specialist at Illusion Dental Laboratory | Biotechnology | Apply Now
Illusion Dental Laboratory, a leader in high-end dental restorative solutions, is hiring a Regulatory Affairs Specialist for its Mumbai facility. This quality assurance job is a technical and compliance-heavy role designed for professionals who can navigate the complexities of medical device registrations across the India, US, and EU markets. As a specialist in this field, you will be responsible for ensuring that dental implants and prosthetic devices meet stringent safety standards before they reach the clinical market.
- Job Position: Regulatory Affairs Specialist
- Location: Mumbai, Maharashtra, India
About the Company
Illusion Dental Laboratory is one of the largest and most technologically advanced dental laboratories in India. Headquartered in Mumbai, the company has spent over 30 years revolutionizing the dental healthcare landscape by providing high-precision restorative solutions, including crowns, bridges, and advanced dental implant systems. A quality assurance job or regulatory role at Illusion Dental means working for an organization that combines traditional craftsmanship with CAD/CAM digital dentistry and 3D printing technologies to serve dentists and patients globally.
Job Overview
This role acts as the bridge between the R&D laboratory and global health authorities. You will translate technical engineering data into the formal dossiers required for legal market entry.
Key Responsibilities:
- Technical Documentation: Prepare and maintain essential regulatory files, including Device Master Files, Risk Management Files, and Design History Files (DHF).
- Global Submissions: Support registrations for India via the CDSCO (SUGAM/NSWS) portals, the US FDA, and the EU under the Medical Device Regulation (MDR) for CE marking.
- Gap Analysis: Conduct thorough reviews of existing technical documentation to identify compliance gaps and rectify them before audit cycles.
- Product Labeling: Draft and update Instructions for Use (IFUs), implant cards, and compliance declarations to meet specific regional labeling laws.
- Audit Support: Coordinate responses for regulatory inspections and audits, ensuring all technical evidence is organized and validated.
Educational & Experience Requirements
To excel in this Regulatory Affairs Specialist role, Illusion Dental Laboratory seeks candidates with the following background:
- Education: Bachelor’s or Master’s in Biotechnology, Microbiology, or Engineering.
- Experience: 1 to 4 years in Regulatory Affairs, ideally within the medical device or life sciences sector.
- Regulatory Knowledge: Familiarity with ISO 13485 (Quality Management Systems for Medical Devices), EU MDR, and 21 CFR Part 820.
Why This Quality Assurance Job is Critical
In the dental industry, precision is paramount. A Regulatory Affairs Specialist ensures that every crown, bridge, or implant manufactured by Illusion Dental is backed by a rigorous Clinical Evaluation Report and Usability Report.
- Collaborative Environment: You will work with Purchase, R&D, and Marketing teams to gather the necessary data for technical submissions.
- Career Growth: Managing submissions for three distinct global markets (India, US, EU) provides a diverse skill set that is highly valued in the international life sciences market.
Securing a Regulatory Affairs Specialist position at Illusion Dental Laboratory is a strategic career move for life science professionals in Mumbai. This quality assurance job offers deep exposure to global medical device regulations, from CDSCO’s SUGAM portal to European CE marking. By ensuring the compliance of innovative dental solutions, you play a direct role in patient safety and international healthcare quality. If you have experience in technical writing and a “go-getter” attitude, apply for this opening in Andheri West today.
