Complaint Handling (CH) & Vigilance Reporting Specialist

Heartstream; Bengaluru; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Heartstream in Bengaluru, India is seeking a skilled Complaint Handling (CH) & Vigilance Reporting Specialist to lead post-market investigations, analyze feedback and data, and ensure regulatory compliance.

You will collaborate with Quality, Regulatory Affairs, Engineering, Manufacturing, Service, and Product Management teams to drive CAPAs and support continuous improvement of complaint handling processes while safeguarding patient safety.

Qualifications

• Bachelor's degree in a relevant field is required.
• Experience in Post-Market Surveillance (PMS), Vigilance Reporting and Complaint Handling (CH) in a medical device environment is preferred.
• Strong analytical and communication skills with ability to translate findings into actionable reports.

Responsibilities

• Lead investigations into post-market complaints and adverse events.
• Conduct end-to-end complaint handling activities with data collection, coding, documentation, analysis, and reporting.
• Collaborate with Quality, Regulatory Affairs, Engineering, Clinical, Manufacturing, Service, and Product Management teams to support investigations and CAPAs.

Skills

Complaint investigation

Root cause analysis

CAPA

PMS

Vigilance reporting

QMS

Data analysis

Technical documentation

Regulatory compliance

Education

Bachelor's degree in Medical Sciences, Healthcare Management, Industrial Engineering, Supply Chain Management, Life Sciences, Engineering, or a related field

Job description

Complaint Handling (CH) & Vigilance Reporting Specialist

Heartstream is building on our 40+ year legacy of growth and innovation in emergency medical technology to continue passionately pursuing our mission of saving lives, lowering the cost of healthcare, and advancing the science of resuscitation while serving the public access AED, EMS, military, and hospital market segments. Heartstream includes leading brands and products like HeartStart AEDs, Intrepid and DFM100 monitor defibrillators, Tempus monitor and Tempus ALS systems, and Corsium and ECI informatics solutions.

Your impact:

• Play a critical role in ensuring the quality, safety, and effectiveness of Heartstream's life-saving medical technologies by leading investigations into post-market complaints and adverse events.
• Conduct complex complaint investigations, analyzing customer feedback, product performance data, technical findings, and service records to identify potential product issues, determine root causes, and support timely resolution.
• Lead end-to-end complaint handling activities, including data collection, coding, documentation, analysis, investigation planning, reporting, and closure in compliance with quality and regulatory requirements.
• Collaborate closely with cross-functional stakeholders including Quality, Regulatory Affairs, Engineering, Clinical, Manufacturing, Service, and Product Management teams to support technical investigations and drive corrective actions where required.
• Utilise complaint and post-market surveillance data to identify trends, safety concerns, and opportunities for product improvements that enhance customer experience and patient outcomes.
• Review and approve customer response communications, ensuring investigations are thoroughly documented and escalated appropriately when regulatory reporting or additional actions are required.
• Support the continuous improvement of complaint handling processes by maintaining coding standards, ensuring data integrity, and contributing to quality system enhancements.
• Assist with training, onboarding, and qualification of new investigators, sharing best practices and helping ensure compliance with complaint handling procedures and global regulatory standards.

Our commitment to collaboration

• Your work will directly improve the quality of emergency medical services and enhance patient safety and survival rates by making high-quality care accessible to more people around the world. As part of a number one provider of therapeutic care solutions, your contribution will help us continue to save more lives every year. With every project, you'll be making a world of difference.
• We believe collaboration is better together than apart. For our office-based teams, this means working in-person at least 3 days per week. Onsite roles require full-time presence in the company's facilities. Field roles are most effectively done outside of the company's main facilities, generally at the customers' or suppliers' locations.
• This role is an office-based role located in Bangalore, India.

You’ll thrive in the role if:

• You hold a Bachelor's degree in Medical Sciences, Healthcare Management, Industrial Engineering, Supply Chain Management, Life Sciences, Engineering, or a related field.
• You've acquired experience in Post-Market Surveillance (PMS), Vigilance Reporting and Complaint Handling (CH), ideally within a medical device environment.
• Your skills include complaint investigation, root cause analysis (RCA), CAPA methodologies, post-market surveillance, adverse event assessment, complaint management systems, quality management systems (QMS), data analysis, technical documentation, vigilance reporting, and regulatory compliance.
• You have strong analytical and problem-solving abilities, with experience evaluating complex technical information and translating findings into clear, actionable reports.
• You have excellent written and verbal communication skills and can effectively collaborate with cross-functional stakeholders while managing multiple investigations simultaneously.
• You're a detail-oriented, quality-focused professional committed to patient safety, regulatory compliance, and continuous improvement.
• You can thrive working independently in a fast-paced environment.