Regulatory Affairs Specialist

Job Title: Regulatory Affairs Specialist

Location:

Employment Type:

About the Role

Regulatory Affairs Specialist

Key Responsibilities

Regulatory Compliance (ISO & CDSCO)

• Lead and maintain end-to-end compliance for

  ISO 15189

  ,

  ISO 13485

  , and other relevant standards.
• Prepare, update, and manage all required documentation, manuals, SOPs, protocols, and logs.
• Coordinate all internal and external ISO audits and ensure timely closure of NCs/CAPAs.
• Oversee

  CDSCO regulatory submissions

  , including Form approvals, device registrations, permissions, and license renewals.
• Maintain a compliance calendar to ensure no deadlines or renewals are missed.

Documentation & Quality Assurance

• Develop, revise, and implement

  Quality Management System (QMS)

  documentation.
• Prepare technical files, dossiers, risk assessments, and validation records.
• Ensure all laboratory practices align with national guidelines and IVD regulatory norms.
• Monitor and maintain QC logs, equipment calibration records, and proficiency testing documentation.
• Carry out routine internal audits, gap analyses, and regulatory risk assessments.
• Implement CAPA processes, track corrective actions, and ensure document traceability.

Regulatory Coordination

• Act as the primary point of contact for regulatory bodies, auditors, and certification agencies.
• Support new product filings, labeling compliance, and regulatory updates as required.
• Track new regulatory requirements and update internal policies accordingly.

Process Improvement

• Identify areas of improvement within the QMS and implement best practices.
• Ensure continuous readiness for audits and inspections.

Qualifications & Requirements

• Bachelor’s or Master’s degree in Life Sciences, Biotechnology, Biochemistry, Microbiology, or related field.
• 2–5 years of regulatory affairs or quality assurance experience (preferably in diagnostics, pathology labs, or IVD industry).
• Strong knowledge of ISO 15189, ISO 13485, NABL guidelines, and CDSCO regulatory processes.
• Excellent documentation skills and strong attention to detail.
• Ability to manage regulatory tasks independently without supervision.
• Strong communication and coordination skills.

What We Offer

• Competitive salary and performance incentives.
• Opportunity to lead regulatory affairs for a fast-growing diagnostics and biotech company.
• Autonomous role with full ownership of compliance and QA functions.