What are the responsibilities and job description for the Regulatory Compliance Expert - Medical Devices position at Intellectt Inc?
Regulatory Compliance Expert - Medical Devices
We are seeking a highly experienced Regulatory Compliance Expert to join our team at Intellectt Inc. The ideal candidate will have a deep understanding of medical device regulatory standards and requirements, with experience in ensuring compliance with applicable regulations and standards.
The successful candidate will be responsible for collaborating on DHF remediation projects, authoring and executing Design History File documents for medical devices, and supporting Research & Development (R&D) or Sustaining Engineering initiatives to enhance product performance and ensure lifecycle continuity.
Responsibilities:
- Collaborate on DHF remediation projects to ensure compliance with applicable regulations and standards
- Author, review, and execute Design History File documents for medical devices
- Support R&D or Sustaining Engineering initiatives to enhance product performance and ensure lifecycle continuity
Requirements:
- Deep understanding of medical device regulatory standards and requirements
- Experience in ensuring compliance with applicable regulations and standards
- Proven track record of success in DHF remediation
- Proficiency in relevant documentation tools and software
