Regulatory Affairs Expert
Fresenius Medical Care
- Location
- Bengaluru, Karnataka, India
- Job type
- Full-time
Required skills
- compliance
- interpersonal skills
- product design
About the role
Fresenius Medical Care
Website:
freseniusmedicalcare.com
Job details:
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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