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NeoDx Biotech Labs Pvt. Ltd., an ISO 13485:2016 certified molecular diagnostics company, is hiring a Regulatory Affairs Specialist / Junior Executive – Regulatory Affairs in Bengaluru. This opportunity is ideal for life science professionals seeking to build a strong career in IVD regulatory affairs, CDSCO submissions, and EU IVDR compliance, particularly within RT-PCR and molecular diagnostics.
This role offers hands-on exposure to design and development (D&D) activities, regulatory documentation, and interactions with regulatory authorities and clinical validation partners.
Key Responsibilities – Regulatory Affairs Specialist
- Support planning and execution of Design & Development (D&D) activities for IVD products
- Maintain D&D records and regulatory documents within the QMS portal
- Identify and strategize appropriate regulatory pathways for IVD product submissions
- Review analytical, stability, and design study data against CLSI, ISO, and regulatory guidelines
- Prepare and manage regulatory documentation for CDSCO, EU IVDR / CE-IVD (FDA knowledge is an advantage)
- Assist in risk management activities as per ISO 14971
- Coordinate with clinical validation partners and engage with regulatory officials
- Perform regulatory submissions on CDSCO and EU IVDR portals
- Support post-market surveillance (PMS) documentation
- Assist Quality Assurance (QA) during audits and design transfer activities
Qualifications & Experience Required
Educational Qualification
- Bachelor’s or Master’s degree in Biotechnology or Life Sciences
Experience
- 1–2 years of experience in Regulatory Affairs (IVD / Medical Devices)
Technical & Regulatory Skills
- Strong hands-on experience in regulatory documentation
- Knowledge of CDSCO regulations and EU IVDR / CE-IVD
- Familiarity with ISO standards (ISO 13485, ISO 14971) and CLSI guidelines
- IVD technical knowledge, especially RT-PCR technology
- Exposure to FDA regulations is an added advantage
Soft Skills
- Strong written and verbal communication skills
- Excellent organizational and time management abilities
- Ability to multitask and work independently or in cross-functional teams
- Analytical mindset with strong attention to detail
Salary & Benefits
- Salary Range: ₹4,00,000 – ₹7,00,000 per annum (INR, based on experience)
- Opportunity to work with an ISO 13485 certified IVD company
- Direct exposure to CDSCO and EU IVDR regulatory submissions
- Career growth in molecular diagnostics and regulatory affairs
- Collaborative and innovation-driven work environment
How to Apply
Interested candidates please email your resume at: hr@neodx.in
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