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Manager Regulatory Affairs
2 months ago
PositionManager RegulatoryAffairsTotalExperience BScwith 57 Years Experience /MSc with 35 YearsExperienceLocationMumbai
Whoare weBased outof IIT Bombay HaystackAnalytics is a HealthTech company creatingclinical genomics products which enable diagnostic labs andhospitals to offer accurate and personalized diagnostics. Supportedby Indias most respected science agencies (DST BIRAC DBT) wecreated and launched a portfolio of products to offer genomics ininfectious diseases. Our genomics based diagnostic solution forTuberculosis was recognized as one of top innovations supported byBIRAC in the past 10 years and was launched by the Prime Ministerof India in the BIRAC Showcase event in Delhi2022.
Responsibilities
- Supportin creating regulatory and quality policy plan as needed internallyand externally
- Work with internal personnel andexternal agencies to implement relevant regulatoryrequirements
- Maintain and submit regular followup documentation to regulatory/ quality agencies and participate inaudits as needed
- Document review andpreparation of submissiondossiers
Requirement
- Preferenceto the candidate with 3 years experience in regulatoryaffairs
- Ability to quickly prioritize andexecute tasks
- Experience in medicaldevices
- Strong analytical skills and attentionto details
- Strong documentationskills
regulatoryaffairs,medical devices,document review,iso,biomedicalengineering
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