Global Statutory Compliance for Dental Implants

Job Description:

Job Overview:

The Manager – Global Statutory Compliance will be responsible for ensuring the company's dental implants and medical devices adhere to international regulatory standards, including ISO 13085, FDA, and other country-specific statutory requirements. This role will involve overseeing the creation and management of Design History Files (DHF), ensuring proper document verification and validation, and maintaining compliance with the Device Market File (DMF) requirements. The candidate will collaborate with cross-functional teams, including R&D, Quality Assurance, and Legal, to ensure all global statutory obligations are met for product development, market approval, and ongoing compliance.

Key Responsibilities:

• Regulatory Compliance Management:

  • Ensure compliance with global medical device regulations, particularly ISO 13085 and other relevant standards.
  • Manage and maintain the Design History File (DHF), ensuring that all regulatory documentation is accurate, complete, and up-to-date.
  • Collaborate with international regulatory bodies to stay informed about changes in compliance standards and ensure company policies align with new regulations.
  • Oversee the preparation and submission of Device Market Files (DMF) to regulatory authorities for product approvals and market entry.
  • Ensure compliance with FDA and other global regulatory requirements, including CE marking for products sold in the European Union.

• Document Verification and Validation:

  • Lead document verification processes, including risk assessments, technical documentation, and clinical data evaluation for new and existing dental implant products.
  • Validate product specifications and manufacturing processes to ensure regulatory compliance and consistency with safety and performance requirements.
  • Review and approve all technical documentation, ensuring accuracy and adherence to regulatory guidelines.

• Quality Assurance Support:

  • Work closely with Quality Assurance teams to ensure product design, development, and manufacturing meet statutory compliance and quality management standards.
  • Participate in internal and external audits to ensure the company’s quality management systems comply with ISO 13485, ISO 13085, and other relevant standards.

• Global Market Entry Support:

  • Prepare regulatory submissions for new product registrations and renewals in global markets.
  • Maintain up-to-date knowledge of changing global regulatory landscapes, particularly in key regions like North America, Europe, and Asia.
  • Ensure timely product registration and market approvals through efficient coordination with regulatory agencies.

• Team Leadership and Development:

  • Lead and mentor a team of regulatory professionals, ensuring they are well-versed in global regulatory requirements.
  • Develop and implement training programs to build internal expertise in statutory compliance and regulatory affairs.

Qualifications:

• Education:

  • Bachelor's or Master's degree in Regulatory Affairs, Biomedical Engineering, Life Sciences, or a related field.

• Experience:

  • Minimum of 5-7 years of experience in regulatory affairs, with a focus on medical devices or dental implants.
  • Strong working knowledge of Design History Files (DHF), Device Market Files (DMF), and document verification/validation processes.
  • Demonstrated experience with ISO 13085, ISO 13485, FDA, CE marking, and other relevant global regulatory standards.

• Skills:

  • Expertise in statutory compliance for medical devices, particularly dental implants.
  • Excellent understanding of regulatory submission processes, including FDA, CE marking, and global product registrations.
  • Strong leadership skills, with experience managing and developing teams.
  • High attention to detail and the ability to manage complex documentation and regulatory requirements.
  • Excellent communication skills and the ability to collaborate with cross-functional teams.

Table of Contents for Regulatory Files:

1. Design History File (DHF):

   • Product Design Specifications
   • Risk Management Plan
   • Design Verification and Validation Reports
   • Clinical Evaluation Reports
   • Manufacturing Process Documentation
   • Post-Market Surveillance Plan

2. Device Market File (DMF):

   • Product Description and Intended Use
   • Summary of Clinical Data
   • Risk Assessment Documentation
   • Manufacturing and Quality Control Procedures
   • Regulatory Submissions and Approvals
   • Labels, Instructions for Use, and Marketing Material

3. ISO 13085 Documentation:

   • Quality Management System Overview
   • Standard Operating Procedures (SOPs)
   • Risk Management Process
   • Internal Audit Reports
   • Certification Documentation
   • Corrective and Preventive Actions (CAPA)