Chief Medical Device Compliance Specialist

1 week ago

Ahmedabad, Gujarat, India beBeeAuditor Full time ₹ 1,50,000 - ₹ 28,00,000
Medical Devices Auditor Job Description

As a Medical Devices Auditor, you will play a crucial role in ensuring the quality and compliance of medical devices.

Key Deliverables:

  1. Plan and conduct audits in accordance with ISO 13485, EU MDR, and MDSAP standards to ensure regulatory compliance.
  2. Review and evaluate technical files and documentation for medical devices to guarantee accuracy and completeness.
  3. Collaborate with audit teams to maintain quality, ensure compliance, and meet client expectations.
  4. Support certification decisions and regulatory reviews in accordance with DNV and accreditation guidelines.

Role Responsibilities:

  1. Execute independent audits and manage auditing teams as needed to ensure efficiency and effectiveness.
  2. Maintain thorough audit documentation and deliver reports promptly to stakeholders.
  3. Ensure adherence to global regulatory and accreditation standards through ongoing monitoring and improvement.
  4. Engage with clients and internal stakeholders to support quality assurance and improve overall performance.

Required Skills and Qualifications:

  • Strong knowledge of medical device regulations, including ISO 13485, EU MDR, and MDSAP standards.
  • Excellent communication and interpersonal skills for effective collaboration and stakeholder engagement.
  • Ability to work independently and manage multiple priorities in a fast-paced environment.
  • Strong analytical and problem-solving skills for reviewing and evaluating technical files and documentation.

Benefits:

  • Opportunity to work on challenging projects and contribute to the development of the organization.
  • Collaborative and dynamic work environment with experienced professionals.
  • Comprehensive training and professional development opportunities to enhance skills and knowledge.

Others:

  • Competitive compensation package that includes salary, bonuses, and benefits.
  • Flexible working hours and remote work options for better work-life balance.
  • Recognition and rewards for outstanding performance and contributions to the organization.

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