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Fresenius Medical Care

Regulatory Affairs Expert

Fresenius Medical Care
Bengaluru, India
8-10 Years
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Job Description

General:

  • Works independently on tasks and projects within the scope of Product Regulatory Affairs, ensuring compliance with applicable regulations and standards.
  • Establishes and manages priorities effectively to meet deadlines and align with business and regulatory requirements.
  • Exercises sound judgment makes informed decisions within their area of responsibility and assumes accountability for outcomes.
  • Provides technical guidance and support to Junior Regulatory Affairs Experts, fostering their development and ensuring high-quality deliverables.

Your responsibilities:

  • Manage global regulatory product documentation, including technical files, registration dossiers, IFUs, and labeling
  • Strong knowledge of global medical device regulations, including MDR 2017/745, FDA SaMD Guidance, IMDRF SaMD Principles, NMPA, and requirements for cloud‑based medical software.
  • Ensure compliance with regulatory standards and testing requirements throughout product design and development
  • Coordinate regulatory approvals and change notifications with Notified Bodies and Authorities
  • Ensure global regulatory product availability aligned with commercial strategy by managing registrations, renewals, and submissions
  • Coordinate regulatory product strategies
  • Drive regulatory assessments for product and process changes, including software updates, patches, cloud‑infrastructure changes
  • Lead regulatory aspects of product and process changes, including regulatory documentation.

Your profile:

  • Master's degree in Technical, Engineering, or Scientific fields
  • Minimum of 8-10 years in Regulatory Affairs or Quality Assurance in Medical Devices or Medicinal Products
  • Knowledge of development and manufacturing processes
  • Familiarity with quality and risk management standards, including ISO 13485, ISO 14971, IEC 62304 (Software Lifecycle), IEC 82304‑1 (Health Software), and IEC 81001‑5‑1 (Health Software Cybersecurity).
  • Strong knowledge of global medical device regulations, including MDR 2017/745, FDA SaMD Guidance, IMDRF SaMD Principles, NMPA, and requirements for cloud‑based medical software.
  • Experience with cybersecurity, data protection (GDPR), and cloud compliance frameworks relevant to medical devices.
  • Lead regulatory strategy for cloud‑hosted medical software, including data protection, cybersecurity, interoperability, and cross‑border data transfer requirements.
  • Strong communication and interpersonal skills
  • Fluent in English, both written and spoken

More Info

Job Type:
Permanent Job
Industry:
Other
Function:
Product Regulatory Affairs
Employment Type:
Full time

Job ID: 149085677

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Last Updated: 11-06-2026 01:58:56 PM
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Regulatory Affairs Expert

Fresenius Medical Care
Bengaluru, India

Skills:

regulatory approvals , regulatory standards , Iso 14971, Iso 13485, Medical device regulations, IEC 60601 series, FDA CFR, NMPA, Regulatory product documentation, Technical files, Risk management standards, Labeling, Change notifications, IFUs, Testing requirements, Registration dossiers