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Manager Regulatory Affairs, Medical Dev

3-5 years
Not Disclosed
10 May 1, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

 

Job Title: Manager – Regulatory Affairs, Medical Devices

Location: New Delhi, Delhi, India
Job ID: 841709
Company: Bayer
Division: Pharmaceuticals
Job Type: Full-time
Reference Code: 841709
Category: Regulatory Affairs / Medical Devices


Position Overview

The Regulatory Affairs Manager for Medical Devices will oversee and manage regulatory submissions and compliance activities for radiology medical devices in India and select South Asian markets. This role involves preparing import license dossiers, handling regulatory authority interactions, monitoring evolving regulations, and supporting internal teams with expert regulatory guidance. It also emphasizes cross-functional collaboration with global and regional regulatory, commercial, supply chain, legal, and quality teams.


Key Responsibilities

1. Regulatory Submissions & Approvals

  • Prepare and submit import license applications for Bayer’s radiology medical devices

  • Ensure timely and accurate regulatory responses to Indian health authorities (e.g., CDSCO)

  • Provide regulatory assessments related to product development and lifecycle changes

2. Compliance & Documentation

  • Review and verify compliance of labeling materials with local standards

  • Maintain updated knowledge of regulatory changes and assess their business impact

  • Track and archive submission dossiers and maintain regulatory activity logs

3. Internal & External Coordination

  • Serve as a regulatory liaison supporting Commercial, Supply Chain, Legal, Quality teams

  • Work closely with Global Regulatory Affairs and APAC Regulatory Head for alignment

  • Support policy research and regulatory strategy for India’s device market


Qualifications

  • Degree: PhD / Master's / Bachelor's in Engineering, Pharmaceutical Sciences, Chemistry, or Biology

  • 3–5 years of India-specific regulatory experience in pharma or medical devices

  • Direct experience with CDSCO and regulatory registrations

  • Familiar with design change assessments and local regulatory systems

  • Strong English communication, negotiation, and organizational skills

  • Ability to work both independently and in cross-functional teams