Company Profile

Vissco Healthcare Pvt Ltd Established in 1963,is one of India's leading manufacturers of orthopaedic supports, rehabilitation products, mobility aids, and wellness solutions. With over six decades of expertise, Vissco is committed to improving mobility, enhancing recovery, and empowering people to lead active, independent lives through innovative and high-quality healthcare products.

Headquartered in Mumbai,Vissco has a strong presence across India and international markets, serving healthcare professionals, hospitals, retailers, and millions of customers worldwide. Driven by innovation, quality, and customer-centricity, Vissco continues to set benchmarks in the healthcare and medical devices industry.

Company Website: https://www.vissco.com/

Key Responsibilities

Regulatory Compliance

- Prepare, compile review, and submit regulatory dossiers for medical device registrations in international markets.
- Ensure compliance with CDSCO, MDR 2017, ISO 13485, CE MDR, and country-specific regulatory requirements.
- Maintain regulatory documentation in accordance with applicable standards and internal procedures.
- Monitor changes in global medical device regulations and communicate their business impact.

Product Registration

- Coordinate new product registrations, renewals, amendments, and license maintenance.
- Liaise with regulatory authorities, notified bodies, distributors, and local regulatory consultants.
- Track registration timelines and ensure timely renewals to prevent product license expiry.

Technical Documentation

- Prepare and maintain:
- Technical Files
- Device Master Files
- Product dossiers
- Free Sale Certificates
- Certificates of Origin
- Declarations of Conformity
- Product specifications and labelling documentation

- Review product labels, Instructions for Use (IFU) and artwork for regulatory compliance.

Cross-functional Coordination

- Work closely with R&D;, Quality Assurance, Manufacturing, Marketing,



Supply ChaiN and International Business teams.
- Support new product launches by ensuring all regulatory approvals are obtained before commercialization.
- Coordinate document requests from distributors and customers.

Quality & Compliance Support

- Participate in internal and external audits.
- Support ISO 13485 Quality Management System documentation.
- Assist in risk management and change control activities related to regulatory submissions.
- Maintain regulatory records and document control.

International Business Support

- Provide regulatory documentation to distributors and overseas customers.
- Support market access initiatives for new countries.
- Coordinate legalisation, notarization, apostille and embassy documentation where required.

Regulatory Intelligence

- Monitor updates from CDSCO, FDA, EU MDR, UK MDR, ASEAN, GCC, and other regulatory agencies.
- Recommend implementation of new regulatory requirements and compliance improvements.

Experience

- 2-6 years of experience in Regulatory Affairs for medical devices or healthcare products.
- Experience with international product registrations is preferred.
- Exposure to orthopaedic or rehabilitation medical devices will be an added advantage.

Required Skills

- Robust understanding of medical device regulations.
- Knowledge of ISO 13485 and Medical Device Rules (India).
- Familiarity with CE MDR documentation and global registration processes.
- Excellent documentation and technical writing skills.
- Strong analytical and organisational abilities.
- Effective communication and stakeholder management skills.
- Ability to manage multiple projects and meet regulatory deadlines.
- Proficiency in Microsoft Office (Excel, Word, PowerPoint).

Preferred Knowledge

- CDSCO Medical Device Rules (MDR 2017)
- CE MDR (EU 2017/745)
- ISO 13485:2016
- ISO 14971 Risk Management
- UDI requirements
- International product registration procedures
- Labelling and artwork compliance

Interested candidates can drop their resume or contact on
[email protected]

📌 Regulatory Affairs Executive (Mumbai)
🏢 Vissco Healthcare
📍 Mumbai