Senior Compliance Manager (Healthcare Industry)

Requirements

• In-depth understanding of regulations and requirements in healthcare (ISO 13485, IEC 62304, ISO 14971, MDR/IVDR, 21 CFR 820, GMP)
• Experience in establishing and maintaining QMS compliant with ISO 13485, IEC 62304, ISO 14971, MDR/IVDR, 21 CFR 820
• Experience in preparing technical documentation for certification and submission to authorities
• Familiarity with the principles and practices of computer system validation related to GAMP 5
• Strong background in conducting audits under ISO 13485, IEC 62304, ISO 14971, MDR/IVDR, 21 CFR 820, GMP requirements
• Ability to communicate complex regulatory requirements clearly and effectively

Would be a plus

• Experience in obtaining CE marking for medical devices

Responsibilities

• Market compliance expertise:
  • Stay informed on regulations (MDR/IVDR, FDA, GMP) relevant to the healthcare industry
  • Identify solutions to help clients achieve faster market entry and regulatory compliance
• Proposal development:
  • Analyze potential client’s needs
  • Develop proposals that align with client expectations and help secure new opportunities
  • Identify potential risks and constraints related to opportunities
  • Communicate with potential clients in case the technical clarification is needed
• Gap analysis:
  • Review client documentation to assess compliance with required regulations or requirements
  • Create detailed gap analyses and plans to meet regulatory requirements
• Partner search and communication:
  • Identify and communicate with potential partners (e.g., eQMS vendors, notified bodies)
  • Ensure selected partners can meet the necessary compliance requirements
• Regulatory updates:
  • Stay up to date changes in regulatory frameworks (MDR/IVDR, FDA 21 CFR 820, GMP), and related regulations or best practices
• Vacancies development and interviews:
  • Create job descriptions to find relevant consultants for opportunities
  • Conduct interviews to find the best candidates for open positions related to the opportunities
• Project involvement:
  • Assist in the initial phases of new projects by creating work plans and compliance documentation