Vantive is hiring for 3 full-time positions in Gurgaon, Haryana, covering Post Market Surveillance and Product Surveillance activities. The openings involve product quality complaints, complaint investigations, regulatory reporting, Medical Device Reporting (MDR), and post-market surveillance documentation.

Job Details

Positions

1. Sr Executive – Post Market Surveillance

Job Requisition: JR-197105

2. Sr Executive – Post Market Surveillance

Job Requisition: JR-197164

3. Sr Executive – Product Surveillance

Job Requisition: JR-197755

All three positions are based in Gurgaon, Haryana.

Responsibilities

Sr Executive – Post Market Surveillance

The selected candidate will be responsible for:

• Evaluating potential product quality complaints and initiating applicable records and actions within the Quality System.
• Owning and processing quality complaints according to applicable procedures.
• Determining, facilitating, and/or approving reportability assessments and decisions.
• Authoring and submitting applicable regulatory reports, including MDR and MIR, when required.
• Monitoring complaint investigations and facilitating resolution and closure.
• Reviewing and approving Engineering, Manufacturing, Quality, Service, and Supplier evaluations and investigations.
• Performing complaint-data queries and ad hoc trend analysis to identify reported product problems and complaints.
• Supporting continuous improvement within the department and organization.
• Implementing and maintaining Post Market Surveillance documents, including PMSP and PSUR, according to the EU Medical Device Regulation.

Sr Executive – Product Surveillance

Responsibilities include:

• Managing and processing complaints and/or MDRs across multiple product lines.
• Opening complaint records and collecting required complaint information.
• Following up with customers through written and verbal communication.
• Determining complaint reportability.
• Creating regulatory reports such as MDRs according to applicable regulations.
• Evaluating complaints for investigation requirements and coordinating sample retrieval.
• Responding to customer complaints.
• Ensuring timely complaint closure according to procedures.
• Managing workflow and escalating issues when required.
• Triaging internal and external complaint-related communication.
• Participating in continuous improvement projects.
• Mentoring and providing training or guidance to new team members when required.

Eligibility / Qualifications

The supplied job description does not provide specific educational qualification requirements.

Required Skills

The roles involve experience or capability in areas including:

• Product quality complaint processing
• Complaint investigation
• Medical Device Reporting (MDR)
• Regulatory reporting
• Complaint reportability assessment
• Post Market Surveillance
• PMS documentation
• PSUR
• PMSP
• EU Medical Device Regulation
• Complaint trend analysis
• Customer complaint communication
• Workflow management
• Cross-functional coordination
• Continuous improvement

Application Details