Manager – Global Regulatory Affairs & QMS (ISO 13485)

1. Global Product Registrations

• Lead regulatory strategy and execution for product registrations across multiple geographies (India, US, EU, Middle East, Asia-Pacific, LATAM, etc.).

• Prepare and submit regulatory dossiers (CDSCO, US FDA, CE/MDR, MOHAP, PMDA, COFEPRIS, etc.).

• Coordinate with Notified Bodies, regulatory consultants, testing labs, and local agents.

• Maintain Technical Files, Device Master Files (DMF), and regulatory documentation.

• Track renewal timelines, variations, and post-approval changes.

2. ISO 13485 – QMS Setup & Management

• Lead implementation and maintenance of ISO 13485 Quality Management System.

• Develop and standardize SOPs, CAPA processes, internal audits, risk management files (ISO 14971).

• Prepare organization for external certification audits.

• Ensure alignment between regulatory documentation and QMS processes.

• Conduct internal audits and compliance reviews periodically.

3. Regulatory Intelligence & Risk Management

• Monitor global regulatory updates and proactively assess impact.

• Manage regulatory risks and mitigation strategies.

• Provide strategic regulatory guidance during product development and sourcing decisions.

4. Cross-Functional Collaboration

• Work closely with Product, Supply Chain, Service Delivery, and Sales teams.

• Support new product launches with regulatory feasibility assessments.

• Coordinate labeling, IFUs, packaging compliance, and UDI implementation.

• Assist in regulatory due diligence for new partnerships or OEM sourcing.

7–15 years of experience in medical device regulatory affairs.

Mandatory experience in a medical device manufacturing company.

Hands-on experience with ISO 13485 implementation and audits.

Strong exposure to multi-country product registrations.

Experience handling technical documentation, CE marking, and US FDA pathways (510(k) preferred).

Excellent documentation, coordination, and regulatory communication skills.