Philips, a global leader in health technology, is hiring a Complaint Handling & Vigilance Reporting Specialist in Pune. This is a high-impact role for experienced professionals in medical device complaint handling, vigilance reporting, MDR/MIR submissions, and quality investigations.
The position offers end-to-end ownership of complex complaint investigations, strong regulatory exposure, and direct interaction with cross-functional teams and health authorities. It is an excellent career opportunity for professionals aiming to grow in Post-Market Surveillance (PMS), Quality Assurance, or Regulatory Affairs within the medical device industry.
Key Responsibilities
As a Complaint Handling & Vigilance Reporting Specialist, you will:
- Lead end-to-end medical device complaint investigations, applying independent judgment within regulatory frameworks
- Develop structured investigation plans, including objectives, methodologies, timelines, and root cause analysis (RCA)
- Document investigation outcomes, conclusions, CAPAs, and preventive actions with high documentation quality
- Perform Good Faith Efforts (GFE) to obtain supplementary complaint data
- Prepare, review, and submit MDR/MIR vigilance reports in compliance with global regulatory timelines
- Investigate and respond to Competent Authority inquiries with accurate, well-supported submissions
- Review and finalize Customer Response Letters (CRLs) and internal regulatory communications
- Analyze complaint trends to identify safety signals, product defects, and improvement opportunities
- Ensure risk assessments adequately address complaint-identified hazards
- Maintain complaint tracking systems ensuring audit readiness and traceability
- Collaborate with Clinical, R&D, Engineering, Manufacturing, Field Service, and Quality teams
- Mentor and support training of new complaint investigators
Required Qualifications & Experience
Experience
- Minimum 5+ years in:
- Medical device complaint handling
- Vigilance / regulatory reporting
- Quality assurance or risk management
- Proven experience with complaint investigations and regulatory submissions (or highly transferable experience)
Education
- Bachelor’s degree in:
- Medical Sciences
- Healthcare Management
- Industrial Engineering
- Supply Chain Management or equivalent
- Master’s degree is a strong advantage
Key Skills
- Strong analytical and critical-thinking ability
- Excellent written and verbal English communication
- Ability to manage multiple cases independently in a regulated environment
- High attention to detail and documentation accuracy
Preferred Skills
- Experience with complaint management systems (TrackWise, Salesforce)
- RCA and CAPA expertise
- Trend analysis and data interpretation
- Mentoring or training experience
Salary & Benefits
- Estimated Salary Range: ₹12,00,000 – ₹20,00,000 per annum (based on experience and expertise)
- Exposure to global regulatory authorities
- Career growth in PMS, Quality, and Regulatory Affairs
- Work on patient-safety-critical investigations
- Hybrid work model (minimum 3 days onsite per week)
- Opportunity to work with a global health technology leader
Why Join Philips?
Philips is a purpose-driven health technology company committed to improving lives through innovation. This role provides meaningful involvement in patient safety, regulatory compliance, and medical device quality, making it an ideal long-term career step for vigilance and regulatory professionals.
How to Apply
