Regulatory Intern

2 days ago

Navi Mumbai Maharashtra, India HaystackAnalytics Full time

**Position**:

- Intern - Regulatory Affairs

**Location**:

- Turbhe, Navi Mumbai

**Education Qualification**:

- Pursuing or completed BSc or MSc in Microbiology, Life Sciences, or Biotechnology

**Who are we**

Based 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 and ISO 15189 compliance
- Undertake activities as part of manufacturing documentation under ISO 13485
- Undertake activities in molecular kit development and kit packaging departments
- Preparation of regulatory document dossier

**Requirements**:

- Have a basic understanding of quality assurance and quality checks
- Awareness of ISO 13485 and ISO 15189

**Skills**
- Keen attention to details.
- Ability to critically evaluate scientific literature and integrate information from multiple sources.
- Ability to work independently with mínimal 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

**Job Type**: Internship

Pay: ₹8,086.00 - ₹10,000.00 per month

Schedule:

- Day shift

Work Location: In person

Application Deadline: 27/03/2025

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