Sr Regulatory Professional
Location: Bangalore, Karnataka, India
Employment Type: Full-Time
Company: Novo Nordisk Global Business Services (GBS)
Position Summary
The Senior Regulatory Professional is responsible for developing and executing global regulatory strategies for medical devices and drug-device combination products. The role focuses on regulatory submissions, technical documentation, change management, health authority interactions, compliance with global device regulations, and providing strategic regulatory guidance throughout the product lifecycle. The position serves as a Subject Matter Expert (SME) for medical device regulatory affairs and supports global product approvals, post-market changes, and regulatory compliance activities.
Key Responsibilities
Regulatory Strategy & Submission Management
Develop and execute global regulatory strategies for medical devices and combination products.
Prepare, compile, review, and submit regulatory dossiers and submission packages.
Ensure timely and high-quality regulatory submissions to global health authorities.
Support product approvals, lifecycle management, and regulatory compliance activities.
Technical Documentation & Regulatory Compliance
Prepare and review Technical Documentation and Common Technical Documents (CTD).
Evaluate scientific and technical documentation for regulatory submissions.
Ensure compliance with MDR and global medical device regulations.
Support maintenance and updates of regulatory documentation.
Change Control & Product Lifecycle Management
Manage Change Requests (CRs) and post-market regulatory changes.
Assess regulatory impact of product modifications and manufacturing changes.
Develop regulatory strategies for global rollouts and lifecycle activities.
Support product maintenance and continuous compliance initiatives.
Health Authority & Notified Body Interactions
Participate in meetings and interactions with Health Authorities.
Support responses to regulatory queries and agency requests.
Represent Regulatory Affairs during audits and inspections.
Collaborate with Notified Bodies for certification and compliance activities.
Cross-Functional Collaboration
Participate in device core teams, development programs, and global project teams.
Collaborate with R&D, Manufacturing, Quality Assurance, Clinical, and Regulatory stakeholders.
Provide strategic regulatory guidance throughout the product development lifecycle.
Support global regulatory alignment across regions and affiliates.
Leadership & Subject Matter Expertise
Serve as a Subject Matter Expert (SME) for medical device regulations.
Mentor and guide junior regulatory professionals.
Provide technical consulting and regulatory pathway guidance to project teams.
Share best practices and support capability building initiatives.
Audit & Inspection Readiness
Support regulatory inspections and Notified Body audits.
Ensure regulatory documentation readiness for inspections.
Participate in audit preparation and remediation activities.
Maintain compliance with global regulatory requirements and quality standards.
Educational Qualification
Graduate or Postgraduate Degree in:
Pharmacy
Biomedical Engineering
Medical Devices
Biotechnology
Engineering
Life Sciences
Experience Required
8+ years of Regulatory Affairs experience.
Experience with Medical Devices and Drug-Device Combination Products.
Strong experience in global regulatory submissions.
Experience managing post-market changes and lifecycle activities.
Exposure to Health Authority interactions and regulatory inspections.
Experience supporting Notified Body audits preferred.
Technical Skills
Regulatory Affairs
Medical Device Regulatory Affairs
Combination Product Regulations
Global Regulatory Submissions
Technical Documentation
Common Technical Document (CTD)
Regulatory Strategy Development
Change Control Management
Product Lifecycle Management
Regulatory Compliance
Regulatory Intelligence
Submission Management
Health Authority Interactions
Regulatory Risk Assessment
Audit Readiness
Inspection Management
Regulatory Knowledge
Medical Device Regulation (MDR)
EU MDR
ISO 13485
ISO 14971
Medical Device Directives
Global Medical Device Regulations
Combination Product Regulations
Post-Market Surveillance Requirements
Quality Management Systems (QMS)
Regulatory Standards & Guidelines
Preferred Skills
Software as a Medical Device (SaMD)
Digital Health Regulations
Notified Body Interactions
Global Product Registration
Regulatory Change Management
Medical Device Lifecycle Management
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Dibrugarh | Diburghar | Guwahati |West Bengal :
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Goa | Panaji | Verna |Bihar :
Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
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Rangpo |India :
Remote, India | Siliguri |Illinois :
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Frank Scottile Blvd |Missouri :
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Mexico |northeastern :
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Oklahoma City |Puerto Rico :
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Tuscaloosa |D.C :
Washington |Delaware :
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Bavaria |Bavaria :
Bayreuth | Erlangen | Munich | Regensburg | Wurzburg |Brandenburg :
Berlin |Baden-Wurttemberg :
Biberach an der Riß | Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen | Ulm |Hesse :
Darmstadt | Marburg |Hessen :
Frankfurt | Harveysburg |Germany :
Germany | GErmany |Lower Saxony :
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Ingelheim am Rhein | Mainz |Schleswig Holstein :
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Saarbrucken |Switzerland :
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Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Istanbul | Turkey |Norway :
Norway | NOrway |Romania :
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Galway |County Dublin :
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China | Quarry Bay |Liaoning :
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Queensland |Melbourne :
South Yarra |United Kingdom :
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Canada |Quebec :
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Brussels |Antwerp :
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Athens | Koropi |Greece :
Greece |North Island :
Auckland |New Zealand :
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Austria |Vienna :
Vienna |Catalonia :
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Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
Estonia | Tartu |Harju County (Maakond) :
Tallinn |Hà Nội :
Hanoi | Hà Nội |Ho Chi Minh :
Ho Chi Minh City |Italy :
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Saitama | Japan |Tokyo :
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Kyiv |Lima Region :
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South Africa | Midrand |Nišava District :
Niš |Bohemia :
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