Regulatory Affairs Expert

Fresenius Medical Care; Bengaluru; On-site; INR 2,500,000 - 4,500,000; Full time

Job summary

Fresenius Medical Care is seeking an experienced regulatory affairs professional in Bengaluru to manage global regulatory documentation and approvals for cloud-based medical software. You will ensure compliance across MDR, FDA SaMD, IMDRF SaMD, and related standards while guiding junior team members.

With 8–10 years in regulatory affairs or quality assurance in medical devices or medicinal products, you will drive regulatory strategies, coordinate with authorities, and oversee changes to

Qualifications

• 8–10+ years in Regulatory Affairs or Quality Assurance in Medical Devices or Medicinal Products
• Strong knowledge of global medical device regulations (MDR, FDA SaMD, IMDRF SaMD, NMPA)
• Experience with cybersecurity, data protection, and cloud compliance for medical devices
• Proven ability to lead regulatory strategy for cloud-hosted medical software

Responsibilities

• Manage global regulatory product documentation (technical files, registration dossiers, IFUs, labeling)
• Coordinate regulatory approvals and change notifications with Notified Bodies and Authorities
• Ensure compliance with regulations throughout product design and development
• Lead regulatory assessments for product/process changes, including software updates and cloud infra changes
• Drive regulatory product strategies and documentation for cloud-hosted software
• Provide technical guidance to junior Regulatory Affairs experts

Skills

Regulatory Affairs

Quality Assurance

Cloud-based medical software

Cybersecurity

Regulatory strategy

Communication skills

English fluency

Education

Master's degree in Technical, Engineering, or Scientific fields

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