Regulatory Affairs Specialist

Primary Role

NeoDx is expanding its diagnostics range and enhancing its clinical and scientific expertise. We are seeking a proactive and detail-focused Regulatory Affairs Executive to join our team in Bengaluru. This full-time, on-site position is ideal for candidates with three to four years of regulatory affairs experience specifically in medical devices, IVD, biotechnology, or diagnostics.

Key Responsibilities

• Determine and support suitable regulatory pathways needed for product registration adhering to applicable regulations.
• Examine design and development data, including analytical performance and stability tests against standards such as ISO and CLSI and regulatory requirements.
• Prepare and review regulatory documentation following relevant regulations like CDSCO, IVDR, and others.
• Assist in preparing and filing regulatory applications for product registrations, renewals, and licenses via CDSCO, NSWS, EU IVDR, and other portals.
• Monitor timelines for submissions, approvals, renewals, and queries while keeping all regulatory records and licenses well organized.
• Collaborate with regulatory bodies, clinical validation partners, and cross-functional internal teams for regulatory processes and submissions.
• Contribute to product risk assessments by supporting risk management efforts in line with ISO 14971.
• Help prepare product documentation such as labeling, packaging, kit inserts, and promotional material ensuring compliance.
• Assist Post-Market Surveillance activities, including complaint handling, product recalls, Field Safety Corrective Actions, and related documentation.
• Maintain adherence to CDSCO and other applicable regulations to ensure seamless regulatory functions.

Candidate Profile

• Excellent attention to detail and strong documentation abilities.
• Good communication and interpersonal skills.
• Enthusiasm to learn regulatory processes and compliance demands.
• Capability to work collaboratively within cross-functional teams.
• Basic understanding of medical device and pharmaceutical regulations is beneficial.
• Proficiency with Google Sheets.
• Ability to coordinate with international partners and teams across different time zones.

Qualifications and Experience

• Bachelor’s or Master’s degree in Biotechnology, Life Sciences, Microbiology, or other Biological Sciences disciplines.
• Candidates with a keen interest in Regulatory Affairs are encouraged to apply.
• Two to four years of experience in Regulatory Affairs, Quality, or related fields in healthcare or medical devices is advantageous.

Additional Skills

• Experience representing the company during CDSCO inspections and audits.
• Strong familiarity with CDSCO regulations, regulatory submissions, and compliance practices.
• Knowledge of ISO 13485 audit processes and quality compliance; Internal Auditor Certification in ISO 13485 is preferred.