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Sr Executive, Product Surveillance

3.00 to 7.00 Years   Gurugram   26 May, 2023
Baxter India
Job LocationGurugram
EducationNot Mentioned
SalaryNot Disclosed
IndustryManufacturing
Functional AreaGeneral / Other SoftwareProduction
EmploymentTypeFull-time

Job Description

    Sr Executive, Product SurveillanceThis is where you save and sustain livesAt Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. Youll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.Baxters products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.Join us at the intersection of saving and sustaining lives where your purpose accelerates our mission.What you ll be doing:
    • Implementation of the Post Market Surveillance requirements as part of the EU Medical Device Regulation including:
    • Gap assessment of current processes and regulation requirements.
    • Implementation of new requirements that align and support peripheral teams and processes.
    • Implementation and maintenance of the Periodic Safety Update Report (PSUR);
    • Implementation and maintenance of the Post Market Surveillance Plan.
    • Implementation and maintenance of the Post Market Surveillance Report.
    • Collaboration 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.
    • Enter and handle complaints as per applicable procedure(s);
    • Execute on projects as required by Manager.
    • Prepare the Canadian Medical device summary reports, to maintain Canada licenses.
    Key Requirements:
    • Min. BSc level (preferably in Life Science or Quality but not mandatory)
    • Experience (0-7 years experience in highly regulated and international environment)
    • Fluent in English (written & spoken)
    • Soft Skills: Self-motivated & committed, details oriented, team player & solution-driven.
    • Able to work from Gurgaon office (Hybrid)
    Reasonable AccommodationsBaxter 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 processRecruitment Fraud Notice Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice .096987Apply Now Save Job,

Keyskills :
post market surveillancemdrsummary reportspms

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