Sr Executive, Post Market Surveillance

Location: Gurgaon, Haryana, India

Company

hirify.global develops vital organ therapies, digital solutions, and advanced services, with a long-standing focus on kidney care and dialysis.

What you will do

• Evaluate potential product quality complaints and initiate the required quality-system records and actions.
• Own and process complaints according to applicable procedures.
• Determine, facilitate, and approve reportability assessments and decisions.
• Prepare and submit regulatory reports, including MDR and MIR, when required.
• Monitor complaint investigations, facilitate resolution and closure, and review or approve evaluations from Engineering, Manufacturing, Quality, Service, and suppliers.
• Query complaint data, perform ad hoc trend analysis, and maintain post-market surveillance documents such as PMSP and PSUR under the EU Medical Device Regulation.

Requirements

• Experience managing product quality complaints within a formal quality system.
• Ability to assess regulatory reportability and prepare competent-authority submissions.
• Knowledge of post-market surveillance documentation and the EU Medical Device Regulation.
• Ability to analyze complaint data and coordinate investigations across technical, manufacturing, quality, service, and supplier functions.

Culture & Benefits

• Full-time employment in Gurgaon, Haryana, India.
• Work focused on improving patient lives through vital organ therapies and dialysis innovation.
• Reasonable accommodations are available for candidates with disabilities during the application and interview process.