🏢 Position Title:
Manager, Product Surveillance
Req #: JR-182070
Location: Gurgaon, Haryana, India
Company: Baxter International Inc.
🧭 Position Overview
Join Baxter’s Quality team where your role contributes directly to patient safety and regulatory compliance. As Manager, Product Surveillance, you will lead a team responsible for end-to-end complaint processing in accordance with global regulatory standards. You will provide subject matter expertise on post-market surveillance and ensure effective team performance, compliance, and operational excellence.
🎯 Key Responsibilities
✅ Team & Process Management
Manage the Product Surveillance team, including hiring, mentoring, coaching, and performance evaluation.
Assign daily complaint processing tasks to ensure timely regulatory reportability determination and reporting.
Monitor and improve key performance indicators (KPIs) and operational metrics.
🧠 Subject Matter Expertise
Act as a Subject Matter Expert (SME) for post-market surveillance processes.
Provide guidance and oversight for complaint handling, regulatory submissions, and product safety reviews.
Review and revise SOPs and quality procedures as needed.
📊 Reporting & Analysis
Regularly update management on team performance, risk trends, and escalations.
Analyze operations metrics and identify opportunities for process improvements.
🔍 Audit & Compliance
Lead or support audit readiness for internal and external audits.
Represent the team during audits by regulatory bodies (e.g., FDA, ISO auditors), including responding to observations and implementing corrective actions.
Support NCRs/CAPAs, risk mitigations, and ensure compliance to regulatory standards.
🤝 Cross-functional Collaboration
Partner with Quality, Engineering, Regulatory Affairs, and other departments.
Participate in or lead cross-functional projects related to complaints, CAPA, or post-market activities.
📌 Qualifications & Skills
🎓 Education
Bachelor’s degree in Science or Engineering (preferred).
💼 Experience
5+ years in Quality, Engineering, Manufacturing, or related field.
Minimum 1–2 years of experience in a supervisory role or
7+ years of relevant experience in Product Surveillance.
🧠 Technical & Soft Skills
In-depth understanding of FDA and ISO regulations, especially as they relate to complaint handling and post-market surveillance.
Strong leadership and people management capabilities.
Excellent critical thinking, problem-solving, and decision-making skills.
Proficiency in technical writing, documentation review, and procedural compliance.
Ability to drive team performance and maintain audit readiness.
Comfort with ambiguity and complex regulatory frameworks.
💡 Success Profile:
Detail Oriented
Critical Thinker
Collaborative
Continuous Learner
Courageous
Influential
🌱 Benefits at Baxter
Support for Parents
Continuing Education & Professional Development
Employee Health & Well-Being Benefits
Paid Time Off
2 Days a Year for Volunteering
📍 Work Location
Baxter (India) Pvt. Ltd
5th Floor, Tower A, Building No.9
DLF Cyber City, DLF Phase III
Gurgaon – 122002, Haryana, India
🌐 Equal Employment Opportunity
Baxter is an Equal Opportunity Employer. All qualified applicants are considered without regard to race, religion, gender, disability, sexual orientation, or veteran status.
♿ Reasonable Accommodations
If you need reasonable accommodation due to a disability or medical condition during the application process, click here to contact Baxter’s accommodation support.
⚠️ Recruitment Fraud Alert
Be cautious of recruitment fraud. Baxter will never request personal financial information or payment during the recruitment process. Learn more by reviewing Baxter’s Recruitment Fraud Notice.
📩 Apply Now
Click here to apply (Insert official application link)
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