AGM/DGM - QMS & Regulatory Affairs - Bhiwadi (Medical Devices Co.)

Job Title: AGM/DGM QMS & Regulatory Affairs

Department: QMS & Regulatory Affairs

Location: Bhiwadi, Rajasthan

Reporting To: Director

Job Summary:

The AGM/DGM QMS & Regulatory Affairs will be responsible for ensuring compliance with all applicable global regulatory standards and quality management systems, focusing primarily on Regulatory Affairs. This includes the preparation, review, and submission of technical files, managing product registrations, and ensuring adherence to key regulatory standards such as EU-MDR 2017, USFDA, ISO 13485, and other applicable international and domestic regulations. The incumbent will lead regulatory strategy development, collaborate cross-functionally to achieve compliance, and act as the primary liaison with notified bodies and regulatory agencies.

Key Responsibilities:

1. Regulatory Strategy Development

• Develop and implement regulatory strategies to ensure the organizations compliance with global medical device regulations.
• Plan and execute strategies for market entry and product registration in India, Europe, the US, and other key geographies.
• Align regulatory strategies with business goals and product development timelines.

2. Regulatory Intelligence & Compliance Monitoring

• Monitor changes in global regulatory landscapes, including EU-MDR 2017, USFDA, and ISO 13485 standards.
• Ensure the company stays up-to-date with current and upcoming regulatory requirements in different markets.
• Provide proactive updates and guidance to internal teams on compliance changes and their potential impact on operations.

3. EU-MDR 2017 Compliance

• Lead compliance efforts for EU-MDR 2017, ensuring that all technical documentation meets regulatory expectations.
• Oversee product conformity assessments and the preparation of CE Marking applications.
• Manage post-market surveillance (PMS) and vigilance reporting as required by EU-MDR.

4. USFDA & Other International Registrations

• Prepare and submit regulatory filings, including 510(k) premarket notifications, PMAs (if applicable), and other international regulatory dossiers.
• Handle medical device listings, establishment registrations, and compliance with USFDA QSR (21 CFR Part 820).
• Facilitate product approvals in emerging markets and maintain documentation for various country-specific regulatory bodies.

5. Technical File Review & Technical Documentation

• Oversee the preparation, review, and approval of technical files and Design Dossiers in accordance with regulatory requirements.
• Ensure that technical files contain all necessary documentation, including risk management files, clinical evaluations, and PMS reports.
• Maintain a systematic approach to document control for ease of audit readiness.

6. Submission of Technical Files

• Submit high-quality, audit-ready technical documentation to notified bodies, regulatory authorities, and other agencies for product certification and approvals.
• Address questions, clarifications, and deficiencies from regulatory agencies promptly and effectively.

7. ISO 13485 Quality Management

• Ensure the organizations Quality Management System is aligned with ISO 13485:2016.
• Conduct regular internal audits and prepare for external audits from notified bodies and regulatory authorities.
• Facilitate management reviews to assess the effectiveness of the QMS and drive continuous improvements.

8. Cross-Functional Collaboration

• Work closely with R&D, Manufacturing, Quality Assurance, and Marketing teams to ensure regulatory compliance throughout the product lifecycle.
• Provide guidance to cross-functional teams during design and development to integrate regulatory requirements.
• Support the training and development of internal teams on regulatory and quality standards.

9. Notified Body & Regulatory Agency Relations

• Act as the primary point of contact with notified bodies, regulatory agencies, and certification bodies.
• Manage the scheduling and execution of audits and assessments by external regulatory agencies.
• Establish strong working relationships with regulatory stakeholders to facilitate smoother approvals and certifications.

Key Skills & Qualifications:

Educational Background:

• Bachelors/Master’s degree in Biomedical Engineering, Regulatory Affairs, Life Sciences, or a related field.
• Professional certifications in Regulatory Affairs (e.g., RAPS) or Quality Systems (e.g., Lead Auditor for ISO 13485) are a plus.

Experience:

• 10–15 years of experience in Regulatory Affairs and Quality Management in the medical device industry, with a focus on capital equipment.
• Proven experience with EU-MDR 2017 compliance and USFDA regulatory filings.

Core Competencies:

Regulatory Knowledge:

• In-depth understanding of EU-MDR 2017, USFDA regulations, ISO 13485, and global regulatory pathways.
• Familiarity with India’s CDSCO regulations and other country-specific requirements.

Technical File Expertise:

• Strong knowledge of technical file structure, including risk management, clinical evaluation reports, and PMS documentation.

Documentation & Submission:

• Expertise in preparing and submitting technical files and regulatory dossiers.

Quality Systems:

• Proficiency in managing ISO 13485 QMS and conducting internal and external audits.

Regulatory Strategy & Intelligence:

• Ability to develop proactive regulatory strategies and monitor compliance trends.

Collaboration & Communication:

• Excellent interpersonal and communication skills for cross-functional collaboration and regulatory negotiations.

Additional Attributes:

• Detail-oriented with strong organizational and project management skills.
• Ability to work effectively under tight deadlines and in a fast-paced environment.
• Strong analytical skills to assess regulatory risks and provide strategic solutions.