Regulatory Affairs Executive

NeoDx Biotech Labs Pvt. Ltd.; Bengaluru; On-site; INR 600,000 - 900,000; Full time

Job summary

NeoDx Biotech Labs Pvt. Ltd. in Bengaluru is seeking a Regulatory Affairs Executive with 2–4 years of regulatory experience in medical devices, IVDs or biotech.

The role supports regulatory compliance for devices, instruments and IVD products, coordinating with internal teams, principals, distributors and authorities to ensure timely submissions. The selected candidate will prepare documentation for CDSCO, IVDR, and other regulatory portals, track submissions, and assist in PMS activities,

Qualifications

• Strong attention to detail and documentation skills.
• Good communication and interpersonal skills.
• Willingness to learn regulatory processes and compliance requirements.
• Ability to work collaboratively with cross-functional teams.
• Flexibility to coordinate with global partners across time zones.

Responsibilities

• Identify regulatory pathways for product registrations per requirements.
• Review study data against ISO/regulatory guidelines.
• Prepare regulatory documentation for CDSCO, IVDR and other regs.
• Submit regulatory applications for registrations, renewals and licences.
• Track timelines for approvals and renewals; maintain records.

Skills

Attention to detail

Documentation

Communication

Interpersonal skills

Cross-functional collaboration

Time-zone coordination

Education

Bachelor’s/Master’s in Biotechnology or Life Sciences

Tools

Google Sheets

Job description

Primary Role: NeoDx is expanding its diagnostics portfolio and strengthening its clinical and scientific capabilities. As part of our continued growth, we are looking for a motivated and detail-oriented Regulatory Affairs Executive to join our team in Bangalore.

This is a full-time, on-site role for candidates with 3–4 years of experience in regulatory affairs within the medical devices, IVD, biotechnology, or diagnostics industry.

The selected candidate will be responsible for supporting regulatory compliance activities for medical devices, instruments, and IVD products, while collaborating with internal teams, principals, distributors, and regulatory authorities to ensure timely submissions and adherence to applicable regulations.

Key Responsibilities:

1. Identify and support appropriate regulatory pathways for product registration based on applicable regulatory requirements.
2. Review design and development study data, including analytical performance and stability studies, against applicable standards (e.g., ISO, CLSI) and regulatory guidelines.
3. Review and prepare regulatory documentation in accordance with applicable regulations such as CDSCO, IVDR, and other relevant requirements.
4. Assist in the preparation and submission of regulatory applications for product registrations, renewals, and licences through CDSCO, NSWS, EU IVDR, and other applicable regulatory portals.
5. Track timelines for applications, approvals, renewals, and query responses while maintaining and organizing all related regulatory records, licenses, and certificates.
6. Coordinate with regulatory authorities, clinical validation partners, and internal cross-functional teams for regulatory activities and submissions.
7. Assessing overall product risk by assisting in facilitating the use of risk management tools and contributing to the risk management evaluations per ISO 14971.
8. Assist in preparation of product-related documents including labelling, packaging, Kit inserts, and promotional materials from a regulatory compliance perspective.
9. Support Post-Market Surveillance (PMS) activities, including complaint handling, product recalls, Field Safety Corrective Actions (FSCA), and associated documentation.
10. Support the team in maintaining compliance with CDSCO and other applicable regulatory requirements to ensure smooth regulatory operations.
11. Ensure design study plans align with applicable standards while assisting QA during design transfer and audits.
12. Stay updated on current regulatory guidelines, standards, notifications, and industry practices, and support internal training on regulatory compliance and documentation practices.

About the Company

NeoDx Biotech Labs Pvt Ltd is a cutting-edge biotechnology company specialising in the development and production of innovative diagnostic solutions. Our mission is to improve healthcare outcomes by providing high-quality, reliable diagnostic products that meet the needs of healthcare professionals and patients worldwide. At NeoDx, we are committed to excellence, innovation, and the continual advancement of biotechnology.

Requirements:

Job Specification:

• Strong attention to detail and documentation skills
• Good communication and interpersonal skills
• Willingness to learn regulatory processes and compliance requirements
• Ability to work collaboratively with cross-functional teams
• Basic knowledge of medical device/pharma regulations will be an advantage
• Proficiency in Google Sheets applications
• Flexibility to coordinate with global partners and teams across different time zones as required

Qualification:

• Bachelor’s or Master’s in Biotechnology / Life Sciences / Microbiology or any Biological Sciences background

Candidates with a strong interest in Regulatory Affairs are encouraged to apply

Experience:

• 2 - 4 years of experience in Regulatory Affairs, Quality, or related healthcare/medical device industry will be an added advantage

Additional Skills (If Any):

• Experience representing the organization during CDSCO visits, audits and inspections.
• Strong knowledge of CDSCO regulations, regulatory submissions, and compliance requirements.
• Experience in ISO 13485 audit handling and quality compliance.
• Internal Auditor Certification (ISO 13485) preferred.