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Senior Compliance Manager Healthcare Industry

1 miesiąc temu

Chmielna Warszawa, Polska Sigma Software Pełny etat

We are looking for an experienced Senior Compliance Manager with a focus on the healthcare domain to enhance our expertise and help expand our business in this area.

As a key player in expanding our healthcare compliance services, you will actively participate in developing proposals, conducting gap analysis, and communicating with potential partners and clients.

Your expertise in regulatory requirements like MDR/IVDR, FDA, and GMP will be essential for driving business success, ensuring healthcare products meet regulatory requirements, and achieving CE marking.

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

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