Manager Regulatory A....
Manager Regulatory Affairs
Posted on :
13-03-2024
Employer Active
1 Vacancy
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Job Description
Req ID : 2621003
Position Manager Regulatory Affairs
Total Experience BSc with 57 Years Experience /MSc with 35 Years Experience
Location Mumbai
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 Indias most respected science agencies (DST BIRAC DBT) 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.
Responsibilities
- Support in creating regulatory and quality policy plan as needed internally and externally
- Work with internal personnel and external agencies to implement relevant regulatory requirements
- Maintain and submit regular follow up documentation to regulatory/ quality agencies and participate in audits as needed
- Document review and preparation of submission dossiers
Requirement
- Preference to the candidate with 3 years experience in regulatory affairs
- Ability to quickly prioritize and execute tasks
- Experience in medical devices
- Strong analytical skills and attention to details
- Strong documentation skills
regulatory affairs,medical devices,document review,iso,biomedical engineering
Employment Type
Full Time
Key Skills
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