Global Statutory Compliance for Dental Implants

Job Description:

Job Summary:

The Manager – Global Statutory Compliance will be responsible for ensuring that Alfa Gate’s dental implants meet stringent regulatory compliance standards required for market access across international jurisdictions, including India (CDSCO), USA (USFDA), China (NMPA), Brazil (ANVISA), Europe (EMA), and UAE (Ministry of Health and Prevention - MOHAP). The position requires deep technical knowledge of global standards such as ISO 13485, ISO 14971, CE marking, Medical Device Regulation (MDR) in the EU, and country-specific requirements like GMP (Good Manufacturing Practice), UDI (Unique Device Identification), and quality management system standards. This individual will lead global compliance strategy development, coordinate with international regulatory bodies, and act as the key liaison for managing all statutory documentation, submissions, and approvals.

The role will involve direct oversight of the preparation and submission of technical dossiers, registration files, and other essential documents for product clearances. The manager will ensure that Alfa Gate’s products are compliant with evolving international regulations and will manage audits and certifications. This role will also involve mitigating risks and providing strategic leadership for compliance operations globally.

Key Responsibilities:

1. Regulatory Compliance and Global Strategy Management:

• Develop and implement a global regulatory compliance framework for Alfa Gate’s dental implant products, ensuring adherence to:
  • ISO 13485(Quality Management Systems for Medical Devices)
  • ISO 14971(Risk Management for Medical Devices)
  • CE Marking(EU)
  • CDSCO(India) standards under Medical Device Rules
  • USFDA 21 CFR Part 820(QSR for Medical Devices in the USA)
  • NMPA(National Medical Products Administration - China)
  • ANVISA(Brazil)
  • Saudi FDA(Saudi Arabia)
  • TGA(Therapeutic Goods Administration - Australia)
  • GMP (Good Manufacturing Practice)regulations in relevant regions
  • UDI (Unique Device Identification)requirements in the USA, EU, and other markets

2. Global Registration and Product Submissions:

• Lead the preparation, compilation, submission, and follow-up of regulatory dossiers for product approvals, including technical files, design dossiers, and clinical evaluations for:
  • FDA India (CDSCO)
  • USFDA (510(k), PMA for high-risk devices)
  • NMPA (China)
  • ANVISA (Brazil)
  • CE Marking (EU MDR)
  • Saudi FDA, UAE MOHAP, and other regulatory authorities
• Develop Regulatory Compliance Plans (RCPs)for new product launches in different geographies, ensuring comprehensive alignment with local regulations and global standards.

3. Risk Management and Product Lifecycle Compliance:

• Manage the full product lifecycle regulatory compliance, including post-market surveillance, vigilance reporting, and risk assessments under ISO 14971.
• Conduct Gap Analysisof emerging regulatory trends, including the MDR transition in the EU and the impact of changes in FDA 21 CFR Part 820.
• Ensure continuous risk management, identification of potential non-conformities, and implementation of corrective actions as per ISO 13485

4. Technical Documentation and Quality Management Systems:

• Maintain and update technical documentation in line with ISO 13485, FDA QSR, and EU MDRrequirements, ensuring that all Quality Management Systems (QMS) comply with global requirements.
• Manage Design History Files (DHFs), Device Master Records (DMRs), and other critical documentation to support regulatory submissions and internal audits.
• Implement UDI (Unique Device Identification)requirements for product traceability across relevant markets (US, EU, China).

5. Regulatory Audits and Certification Management:

• Coordinate and manage internal and external audits from regulatory authorities, Notified Bodies, and third-party auditors, including:
  • FDA Inspections (USFDA)
  • Notified Body Audits for CE Certification
  • CDSCO India (Medical Device Rules, 2017)
  • ANVISA Brazil
  • NMPA China
  • GCC Health Ministries
• Manage third-party certifications, such as ISO 13485:2016, and ensure successful re-certifications across global markets.

6. International Liaison and Regulatory Body Communication:

• Serve as the primary point of contact for regulatory authorities globally, maintaining relationships with agencies such as:
  • CDSCO (India)
  • USFDA (USA)
  • NMPA (China)
  • ANVISA (Brazil)
  • EMA (European Medicines Agency)
  • UAE MOHAP (Ministry of Health and Prevention)
  • Saudi FDA
  • TGA (Australia)

7. Product Market Readiness and Compliance:

• Lead the compliance and registration processes to ensure timely product launches, meeting local and global regulations in the most efficient manner.
• Develop comprehensive market entry strategies by aligning with legal, technical, and compliance requirements in countries like India, USA, China, Brazil, Germany, and UAE.
• Manage compliance strategies for GMP, UDI, and MDR-related changes that impact product certification and market entry.

8. Stakeholder and Cross-Functional Collaboration:

• Collaborate with R&D, Quality Assurance, Marketing, and Legal teams to embed regulatory compliance into product development and launch processes.
• Ensure alignment between internal stakeholders to manage regulatory submissions and certifications efficiently.

Key Result Areas (KRA):

1. Global Regulatory Compliance:
   • Ensure full regulatory compliance with ISO 13485, CE Marking, FDA India (CDSCO), USFDA (USA), NMPA (China), ANVISA (Brazil), and other international standards.
2. Regulatory Filings and Submissions:
   • Manage timely submissions of regulatory filings globally, ensuring a 95% on-time approval ratefor market registrations.
3. Audit Management:
   • Lead audits (internal and external) to achieve 100% audit success ratewith no critical non-conformities.
4. Regulatory Documentation Accuracy:
   • Ensure regulatory documentation meets 100% accuracy and completeness, reducing submission rejections.
5. Market Entry Readiness:
   • Successfully manage regulatory processes to enable on-time market entryin new regions.
6. Regulatory Updates and Risk Mitigation:
   • Implement regulatory changes within 30 days of release, ensuring compliance with updated standards.
7. Stakeholder Engagement:
   • Maintain strong relationships with 90% positive feedbackfrom regulatory authorities and internal stakeholders.

Key Performance Indicators (KPI):

1. Timely Regulatory Filings:
   • KPI:100% on-time submission of regulatory filings to CDSCO (India), USFDA (USA), NMPA (China), and other authorities.
   • Target:Zero late submissions.
2. Regulatory Approval Success Rate:
   • KPI:Achieve 95% success in first-time approvals across key markets, including India, USA, China, and Brazil.
3. Audit Performance:
   • KPI:100% compliance during audits, with zero major findings during regulatory audits by USFDA, ANVISA, CDSCO, etc.
4. Compliance Documentation Accuracy:
   • KPI:99% accuracy in technical and regulatory documentation, ensuring smooth audits and submissions.
5. Market Readiness and Timely Launches:
   • KPI:90% on-time market entry for new products, ensuring all regulatory barriers are cleared.
6. Implementation of Regulatory Changes:
   • KPI:100% compliance with new regulations within 30 days of regulatory change announcements.

Qualifications:

• Education:
  • Bachelor’s or Master’s degree in Life Sciences, Biomedical Engineering, Pharmaceuticals, or Regulatory Affairs.
  • RAC Certificationor equivalent regulatory certification is highly preferred.
• Experience:
  • Minimum 10 years of experiencein regulatory affairs, specifically in medical devices or dental implants.
  • Proven expertise in managing regulatory submissions and approvals for medical devices globally.
• Technical Skills:
  • Strong knowledge of ISO 13485, ISO 14971, CE Marking, FDA QSR (21 CFR 820), GMP, UDI, and MDR.
  • Excellent project management and documentation skills for handling global regulatory submissions.

This highly technical role demands a global regulatory compliance expert capable of driving Alfa Gate’s market readiness and statutory approvals across international markets, ensuring successful product launches and adherence to ever-evolving regulations.