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.

Regulatory Documentation
- Preparation, maintenance, review, and approval of global regulatory product documentation, including Global Technical Documentation and Registration Files, ensuring strategic alignment and compliance.
- Oversee the development, harmonization, and approval of content for Instructions for Use (IFU), Service Manuals (SM), Installation Guides (IGL), and product labeling to meet global regulatory and market requirements.
- Serve as a subject matter expert,



providing advanced regulatory guidance and interpretation of compliance standards and associated testing strategies.
- Advise and collaborate with cross-functional teams on regulatory considerations in design and development projects, influencing product and process decisions.
- Manage and approve change notifications submitted to Notified Bodies and Regulatory Authorities, ensuring timely and accurate communication.
- Drive and oversee conformity assessments for current medical devices (nMD), medical devices (MD), and other regulated products, ensuring alignment with risk classifications and applicable standards.
- Author and validate expert opinions and risk evaluations to support product compliance documentation.
- Conduct the preparation of the technical content for Clinical Evaluation Plans and Reports, ensuring robustness and regulatory adequacy.

Product Registration
- Ensure and strategically guide regulatory product availability in glob

📌 Regulatory Affairs- Senior Specialist (Bengaluru)
🏢 Fresenius Medical Care
📍 Bengaluru