Regulatory Affairs Expert

Freseniusmedicalcare; Bengaluru; On-site; INR 1,500,000 - 2,200,000; Full time

Job summary

Fresenius Medical Care in Bengaluru seeks an experienced Regulatory Affairs Expert to manage global regulatory documentation for medical devices and cloud-based software, ensuring MDR 2017/745, FDA SaMD guidance, and IMDRF principles are met throughout product design and development.

You will lead regulatory strategy, coordinate with Notified Bodies and authorities, oversee changes, cybersecurity and data protection (GDPR) where applicable, and mentor junior team members.

Qualifications

• Master’s degree in Technical, Engineering, or Scientific fields.
• 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, IEC 82304‑1, IEC 81001‑5‑1.
• Strong knowledge of global medical device regulations, including MDR 2017/745, FDA SaMD Guidance, IMDRF SaMD Principles, NMPA, and 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.

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.

Skills

Regulatory Leadership

Medical Devices

Cloud Software Regulation

Data Privacy

Cybersecurity

MDR 2017/745

Education

Master's degree in Technical/Engineering/Scientific field

Tools

ISO 13485

IEC 62304

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