Regulatory Affairs Expert
Fresenius Medical Care · Bengaluru · onsite · Posted 47d ago
Not disclosed8–10 yrsfulltimeSourced from
About a minute. You'll make an account on the way through.
About this role
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.
- 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.
- 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
Sourced from foundit
Skills
cloud compliance frameworksFDA SaMD Guidanceglobal medical device regulationsIMDRF SaMD PrinciplesISO 13485data protectionGdprIEC 62304Iso 14971Cyber Security
About Fresenius Medical Care
Fresenius Medical Care
Healthcare
201
employees
1996
30 years old
Massachusetts
United States
₹8.2L PA avg
Avg at Fresenius Medical Care
About
Innovative products, therapies and services creating a future worth living for our patients. Chronic and acute kidney dialysis and therapeutic apheresis.
Industries
Healthcare
Employee ratings
10 reviews
3.6/ 5
Culture
3.2
Career growth
2.5
Work-life
3.4
Employees rate it well for
Job Security37Overall Company36
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