Position - Assistant Manager Quality and Regulatory
Location - Turbhe, Navi Mumbai
Education Qualification -MSc, B. Tech, M. Tech, B. Eng
Company Website - https://haystackanalytics.in/
Who Are We
Spun out of IIT Bombay, HaystackAnalytics is a HealthTech company creating clinical genomics products, which enable diagnostic labs and hospitals to offer accurate and personalized diagnostics. Supported by India's most respected science agencies (DST, BIRAC, DBT, etc.), we created and launched a portfolio of products to offer genomics in infectious diseases. Our genomics-based diagnostic solution for Tuberculosis was recognized as one of top innovations supported by BIRAC in the past 10 years, and was launched by the Prime Minister of India in the BIRAC Showcase event in Delhi, 2022.
What We Want You To Do
- 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
- Strong interpersonal and communication skills with the ability to interact professionally with diverse stakeholders
Skills: medical device,capas,iso,risk management consulting
