Senior Regulatory Affairs Specialist

Fresenius Medical Care

Senior Specialist in Regulatory Affairs at Fresenius Medical Care managing compliance for medical devices and providing guidance on regulatory standards. Overseeing documentation, assessments, and approvals for global markets.

Posted 6/25/2026full-timeBengaluru • 🇮🇳 IndiaSeniorWebsite

About the role

Key responsibilities & impact

Ensure compliance with applicable regulations and standards
Establish and manage priorities effectively to meet deadlines
Author and validate expert opinions and risk evaluations
Lead the drafting, review, and approval of Declarations of Conformity
Oversee local assessments of regulatory impacts
Act as regulatory project leader for significant change initiatives

Requirements

What you’ll need

Works independently on tasks and projects within the scope of Product Regulatory Affairs
Technical guidance and support to Junior Regulatory Affairs Experts
Prepare, maintenance, review, and approval of global regulatory product documentation
Oversee the development and approval of content for Instructions for Use (IFU)
Provide advanced regulatory guidance and interpretation of compliance standards
Collaborate with cross-functional teams on regulatory considerations
Drive and oversee conformity assessments for medical devices and other regulated products
Conduct the preparation of technical content for Clinical Evaluation Plans and Reports

Benefits

Comp & perks

Health insurance
Flexible work arrangements
Professional development opportunities

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

regulatory compliancerisk evaluationregulatory documentationconformity assessmentsClinical Evaluation PlansClinical Evaluation ReportsInstructions for Use (IFU)technical guidanceproject management

Soft Skills

independent workprioritizationleadershipcollaborationcommunication