Job Title: Senior Executive – Product Surveillance
Location: Gurgaon, India
Summary:
Vantive, a global leader in vital organ therapy and kidney care solutions, is seeking a highly motivated and experienced Senior Executive for Product Surveillance. This critical role within our Quality Control team will be responsible for ensuring timely and accurate processing of product complaints, maintaining compliance with global medical device regulations, and contributing to the continuous improvement of our quality systems. If you have a strong background in medical device complaint handling, quality systems, and a passion for patient safety, we encourage you to apply.
About Vantive:
Vantive, formerly Baxter Patient Care Products, is a leading innovator in vital organ therapy, dedicated to advancing kidney care and dialysis solutions. With over 70 years of experience, we are committed to developing and delivering life-saving medical devices that improve patient outcomes worldwide. Our culture is built on a foundation of patient safety, digital transformation, and quality excellence.
Job Description:
As a Senior Executive, Product Surveillance, you will play a key role in maintaining the integrity of our product surveillance program and ensuring compliance with regulatory requirements. Your responsibilities will include:
Key Responsibilities:
- Complaint Management:
- Review open complaints daily to ensure on-time closure per established Key Performance Indicators (KPIs).
- Log and process complaints accurately and efficiently in the TrackWise Complaint Management System (CMS).
- Review complaint files to ensure adherence to internal Standard Operating Procedures (SOPs) and procedural compliance.
- Collaboration & Communication:
- Coordinate effectively with country quality teams, manufacturing units, service teams, and other stakeholders to gather relevant information and resolve complaints.
- Foster strong working relationships with cross-functional teams to ensure seamless communication and collaboration.
- Regulatory Compliance:
- Support regulatory reporting applicability assessments to ensure compliance with global medical device regulations.
- Maintain a thorough understanding of relevant regulations, including MDR, ISO 13485, EU MDR, and FDA 21 CFR 820.
- Data Analysis & Reporting:
- Prepare weekly dashboards, complaint trends, and pending due diligence reports to identify potential issues and areas for improvement.
- Assist with Management Review inputs and provide data analytics to support informed business decisions.
- Quality Systems:
- Contribute to the continuous improvement of our quality systems by identifying and implementing best practices.
- Ensure alignment with global medical device compliance and vigilance frameworks.
Qualifications and Competencies:
- Education: Bachelor’s Degree in Pharmacy, Biomedical Engineering, Life Sciences, or a related field.
- Experience:
- Proven experience in medical device complaint handling.
- Experience in quality systems (QMS), TrackWise CMS, CAPA (Corrective and Preventive Action), or vigilance reporting.
- Familiarity with regulatory requirements, including MDR, ISO 13485, EU MDR, and FDA 21 CFR 820 (an advantage).
- Skills:
- Strong stakeholder communication and cross-functional collaboration skills.
- Excellent analytical and problem-solving abilities.
- Ability to work effectively in a compliance-driven, high-accuracy environment.
- Proficiency in data analysis and reporting.
- Detail-oriented with a commitment to quality and accuracy.
Why Join Vantive?
- Impactful Work: Contribute to the development and delivery of life-saving medical devices that improve patient outcomes.
- Global Leader: Be part of a global leader in vital organ therapy innovation.
- Growth Opportunities: Enjoy competitive compensation and opportunities for long-term career growth within a dynamic and expanding organization.
- Culture of Excellence: Work in a culture focused on patient safety, digital transformation, and quality excellence.
- Meaningful Contribution: Play a vital role in ensuring the safety and efficacy of our products and improving the lives of patients worldwide.
How to Apply:
If you are a qualified and passionate individual seeking a challenging and rewarding career opportunity, we encourage you to apply. Please submit your resume and cover letter outlining your qualifications and experience for this position.