Position - Assistant Manager Quality and Regulatory
Location - Turbhe, Navi Mumbai
Education Qualification - MSc, B. Tech, M. Tech, B. Eng
Responsibilities
- Execute required activities as part of ISO 13485, 15189, 27001 and ISO 62304 compliance
- Create, revise, and maintain relevant policies and procedures.
- Provide support for internal and external compliance audits.
- Perform periodic assessments and risk evaluations.
- Undertake activities relating to regulatory submissions for software as a medical device
Requirements
- The candidate must have the ability to execute tasks and document information independently.
- Have an understanding of medical devices, quality assurance and quality checks
- Awareness of ISO 13485, 15189, 27001 and ISO 62304.
- Internal auditor certification for ISO 13485, 15189, 27001 or ISO 62304 is preferable.
- An understanding of regulatory pathways is preferable.
Skills
- Keen attention to details.
- Ability to critically evaluate scientific literature and integrate information from multiple sources..
- Ability to work independently with minimal supervision as well as collaboratively in a team environment.
- Excellent organizational and time management skills with the ability to prioritize tasks effectively
- Solid interpersonal and communication skills with the ability to interact professionally with diverse stakeholders
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