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
Andra Pradesh :
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Siliguri |Jharkhand :
Ranchi |Karnataka :
B.G Nagara | Bangalore | Belgaum | Bengaluru | Bommasandra | Mangaluru | Mysore | Udupi |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Madhya Pradesh :
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Detroit | Houghton Lake | Macomb | Southfield |Minnesota :
Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Missouri :
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Basel | Zurich |Carlow :
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Brinny | Ringaskiddy |County Dublin :
Swords |Dún Laoghaire :
Dún Laoghaire |Galway :
Galway |Meath :
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China | Quarry Bay |Hubei :
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Hangzhou |Melbourne :
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Ballina | Sydney |Queensland :
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Remote Australia |Republic of Western Australia :
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Amsterdam |Netherlands :
Netherlands |Noord Holland :
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England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |Buenos Aires :
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Vienna |Antwerp :
Heist op den Berg |Brussels :
Brussels |Flemish Brabant :
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Canada |Ontario :
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Lyon | Paris |Attica :
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Japan | Saitama |Tokyo :
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Dubai |Hà Nội :
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