Post Market Surveillance Associate - Chinese/Mandarin Language ExpertReq # JR - 027945 Location Gurgaon, Haryana, India Job Category Quality Control Date posted 10/16/2020
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We believe every person deserves a chance for a healthy life, free from illness and full of possibility. We see a world full of healing, with viable care options available to those with limited choices today. We envision new ways of providing physicians, pharmacists and nurses with technologies that not only treat chronic diseases, but also work to prevent them. We’re looking for team members who are motivated to learn, grow and innovate, while making a meaningful difference for millions of people around the world.
Learn more about how Baxter is At the Intersection of Saving and Sustaining Lives.
Baxter provides a broad portfolio of essential renal and hospital products, including home, acute and in-centre dialysis; sterile IV solutions; infusion systems and devices; parenteral nutrition; surgery products and anesthetics; and pharmacy automation, software and services. The company’s global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries. Baxter’s employees worldwide are building upon the company’s rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care
- Implementation of the Post Market Surveillance requirements as part of the EU Medical Device Regulations including:
oGap assessment of current processes and regulation requirements;
oImplementation of new requirements that align and support peripheral teams and processes;
oImplementation and maintenance of the Periodic Safety Update Report (PSUR);
oImplementation and maintenance of the Post Market Surveillance Plan;
oImplementation and maintenance of the Post Market Surveillance Report;
oCollaboration with cross-functional teams to support EU MDR requirements, escalations, and updates.
·Analyze complaint and product failure data;
·Participate and/or Lead Active Market Surveillance activities (i.e. surveys, etc.).
·Provide feedback and escalate any concerns or issues within the process.
·Support execution and improvements to the current PMS processes.
·Pro-actively recognizes and identifies current and future problems, structures them and quickly translates them into solutions and opportunities.
·Execute on projects as required by Manager.
EEO (Equal Employment Opportunity)
Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.