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Fresenius Medical Care

Regulatory Affairs Expert

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

Regulatory Affairs Expert (Medical Devices)

Your responsibilities:

  • Manage global regulatory product documentation, including technical files, registration dossiers, IFUs, and labeling
  • 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
  • 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 management and risk management standards (e.g., ISO 13485, ISO 14971, IEC 60601 series)
  • Understanding of medical device regulations (e.g., FDA CFR, NMPA, MDR 2017/745)
  • Strong communication and interpersonal skills
  • Fluent in English, both written and spoken

Our offer for you:

There is a lot you can discover at Fresenius Medical Care, because we have a lot to offer. No matter in which field you are an expert (m/f/d) and how much experience you bring with you - for your professional future with meaning:

  • The option to work on a hybrid basis
  • Whether in front of or behind the scenes - you are helping to make ever better medicine available to more and more people around the world
  • Individual opportunities for self-determined career planning and professional development
  • A corporate culture in which there is enough room for innovative thinking - to find the best solution together, not the quickest one
  • A large number of committed people with a wide range of skills, talents and experience
  • The benefits of a successful global corporation with the collegial culture of a medium-sized company


More Info

Job Type:
Permanent Job
Industry:
Other
Function:
Regulatory Affairs In Medical Devices
Employment Type:
Full time

Job ID: 149085871

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Last Updated: 11-06-2026 01:59:06 PM
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Skills:

Gdpr, Data Protection, Cybersecurity, Iso 14971, regulatory product documentation, IEC 62304, Iso 13485, IMDRF SaMD Principles, global medical device regulations, FDA SaMD Guidance, cloud compliance frameworks