Sr Regulatory Professional
Company: Novo Nordisk Global Business Services (GBS)
Location: Bangalore, Karnataka, India
Department: Regulatory Affairs – Device & Digital Health
Experience: 8+ Years
Job Level: 7
About the Role
Novo Nordisk is seeking a Senior Regulatory Professional to support global regulatory activities for medical devices and drug-device combination products. The role involves developing regulatory strategies, preparing and submitting regulatory dossiers, managing post-approval changes, supporting health authority interactions, and ensuring compliance with global regulatory requirements.
The successful candidate will act as a Subject Matter Expert (SME) for medical device regulatory affairs, providing strategic guidance to project teams while supporting product development, lifecycle management, and global market approvals.
Key Responsibilities
Regulatory Submissions & Documentation
Prepare, compile, review, and submit high-quality regulatory dossiers and submission packages.
Develop and maintain Technical Documentation (TD) and CTD submissions.
Support global product registrations and regulatory approvals.
Ensure compliance with applicable regulatory requirements and standards.
Regulatory Strategy & Lifecycle Management
Develop regulatory strategies for medical devices and combination products.
Support global product launches and market expansion activities.
Manage post-approval regulatory changes and lifecycle maintenance activities.
Evaluate regulatory impact of product modifications and change requests.
Health Authority & Notified Body Interactions
Lead and support interactions with Health Authorities and Notified Bodies.
Participate in regulatory meetings and agency communications.
Prepare responses to regulatory questions and deficiency requests.
Support regulatory inspections and audits.
Technical Review & Compliance
Review device-related protocols, reports, and technical documentation.
Assess scientific and technical data for regulatory submissions.
Ensure compliance with MDR and applicable international standards.
Support risk-based regulatory decision-making.
Cross-Functional Collaboration
Participate in:
Device Core Teams
Development Projects
Manufacturing Support Activities
Product Launch Teams
Global Project Teams
Collaborate with Regulatory Affairs, Quality, R&D, Manufacturing, and Supply Chain teams.
Provide regulatory guidance throughout the product lifecycle.
Mentorship & Subject Matter Expertise
Serve as a regulatory SME for medical devices and combination products.
Mentor junior regulatory professionals.
Provide technical guidance on global regulatory pathways and requirements.
Support capability development within the regulatory team.
Required Qualifications
Education
Graduate or Postgraduate Degree in:
Pharmacy
Biomedical Engineering
Engineering
Life Sciences
Related Scientific Discipline
Experience
8+ years of experience in:
Regulatory Affairs
Medical Device Regulatory Submissions
Combination Product Regulatory Affairs
Global Regulatory Strategy
Experience managing global regulatory submissions and post-market changes.
Experience supporting product lifecycle management activities.
Required Skills
Regulatory Affairs
Medical Device Regulations (MDR)
Technical Documentation (TD)
CTD Submissions
Combination Products
Global Regulatory Strategy
Regulatory Compliance
Health Authority Interactions
Notified Body Audits
Lifecycle Management
Change Control Management
Risk Assessment
Regulatory Intelligence
Cross-Functional Collaboration
Stakeholder Management
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