Regulatory Affairs Executive

2 days ago

Karapakkam Chennai Tamil Nadu, India CellBios Healthcare & Lifesciences Pvt. Ltd Full time

**Key Responsibilities**:

- **Regulatory Compliance**:
Ensure compliance with ISO 13485, EU MDR 2017/745, US-FDA, CDSCO, and other applicable international standards for medical devices.
- **Submissions and Approvals**:
Prepare, review, and submit regulatory documentation, including 510(k) and IMDR submissions, to regulatory authorities such as US-FDA, CDSCO, and European Notified Bodies.
- **Product Registration**:
Manage the release and registration of product variants in compliance with regional and country-specific regulations (ASPAC, LATAM, USA, CE MARK, EMEA, and MEAST).
- **Post-Market Clinical Follow-Up (PMCF)**:
Participate in PMCF activities to monitor product performance and safety, ensuring compliance with evolving regulatory requirements.
- **Documentation**:
Maintain accurate and up-to-date technical documentation, labeling, and regulatory files necessary for product approvals and renewals.
- **Communication with Regulatory Bodies**:
Serve as a liaison between the company and regulatory authorities, addressing inquiries, facilitating audits, and providing responses to regulatory feedback.
- **Regulatory Strategy**:
Develop and execute regulatory strategies for timely product approvals and market entries across multiple regions.
- **Risk Management**:
Support risk management activities and ensure compliance with post-market surveillance requirements.
- **Collaboration**:
Collaborate with cross-functional teams, including quality, product development, and marketing, to ensure regulatory requirements are integrated into product development.

**Qualifications and Skills**:

- Minimum of 4 years of experience in Regulatory Affairs within the medical healthcare industry.
- Strong knowledge of ISO 13485, EU MDR 2017/745, US-FDA, CDSCO, 510(k), IMDR, and PMCF processes.
- Experience with regulatory submissions and product registrations in global markets, including ASPAC, LATAM, USA, CE MARK (Europe), EMEA, and MEAST.
- Strong technical writing and documentation skills.
- Excellent organizational and project management abilities.
- Effective communication skills for interacting with regulatory authorities and internal teams.

Pay: ₹25,000.00 - ₹50,000.00 per month

Schedule:

- Day shift

Work Location: In person

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