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Regulatory Affairs Expert

Fresenius Medical Care

Bangalore, KA, India · HybridFull-timePosted 3w agoStill listed 3 days ago

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At a glance

Compensation
No compensation found
Location
Bangalore, KA, IndiaHybrid
Schedule
Full-time
Work Authorization
Not specified

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Requirements

Credentials this posting asks for.

Master's degree

Job overview

The Regulatory Affairs Expert works independently on product regulatory tasks, managing documentation, approvals and change notifications while ensuring compliance with global medical device regulations and standards. They coordinate with notified bodies, lead regulatory strategies for cloud‑based software, and guide junior staff, aligning regulatory activities with commercial goals and product development timelines.

Skills & qualifications

RequiredNice to have

Skills

Global Medical Device RegulationsMDR 2017/745FDA SaMD GuidanceIMDRF SaMD PrinciplesNMPACloud‑Based Medical SoftwareISO 13485ISO 14971IEC 62304IEC 82304‑1IEC 81001‑5‑1GDPRCybersecurityData ProtectionRegulatory DocumentationTechnical FilesRegistration DossiersIFUsLabelingChange NotificationsNotified BodiesRegulatory ApprovalsProduct StrategySoftware UpdatesCloud InfrastructureInteroperabilityCross‑Border Data Transfer

Qualifications

Master's in Technical Engineering or Scientific Fields8-10 Years Regulatory Affairs ExperienceFluent English

Full 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

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