Assistant Manager Quality and Regulatory
Haystack Analytics · Mumbai · onsite · Posted 65d ago
About a minute. You'll make an account on the way through.
About this role
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
- 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.
- 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
Sourced from foundit
Skills
About Haystack Analytics
Haystack Analytics
HiringDelivery Analytics for Software Teams
6
employees
2018
8 years old
Mumbai, Maharashtra
India
₹9.3L PA avg
Avg at Haystack Analytics
About
We at Haystack are building state-of-the-art genomics technology for accurate personalized clinical decisions. Our innovations make genomics to work for clinicians, hospitals and labs with scalable, affordable and easy to onboard solutions.
We are keen on empowering healthcare experts to save lives faster and better.
Easy to induct and easy to manage, Haystack's products do not need upskilling to be onboarded.
Accessible nationwide, we are bringing genomics to your fingertips.
We are a technology platform for hospitals and diagnostics labs to provide genomic diagnostics to their clinicians and patients. We build, validate and offer tests that accurately identify the condition of the patient and the tests are brought to you by our most trusted partners.
Our technology benefits everyone. With our easy to set up genomic testing platform, our partner hospitals and diagnostic labs provide accurate reporting for their patients. These reports are based on genomic analysis, and are readily usable by the clinicians.
Industries
Employee ratings
10 reviews
Culture
1.3
Career growth
1.7
Work-life
1.3
Employees rate it well for
Find them on