Sr Executive, Product Surveillance

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies. Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients that is what Vantive aspires to deliver.

We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don t settle for the mediocre. Each of us is driven to help improve patients lives worldwide. Join us in advancing our mission to extend lives and expand possibilities.

Post-market surveillance involves collecting, analyzing, and interpreting data related to medical device use in real-world clinical settings. The Post Market Surveillance Associate will be responsible for drafting, analyzing and issuance of Periodic Safety Update Reports in accordance with EU and other country Regulations.

Essential Duties and Responsibilities:

• Drafting and issuance of Post Market Surveillance Plans as per the requirement.
• Collect and analyze the required data and Draft the Periodic Safety Update Reports and Post Market Surveillance Reports.
• Evaluate the emerging risks from the data analyzed.
• Working with the stakeholders to address the issues, roadblocks keeping the process smooth.
• Timely issuance of PMS Documents.
• To work with the team to streamline the PMS process.
• Also support the complaint process by owing and processing quality complaint as per applicable procedures.
• Author and submit applicable regulatory reports (MDR, MIR, etc) to competent authorities when deemed required.
• Performs other duties as needed and assigned.

Qualifications:

• Excellent verbal and written communication skills.
• Analytical approach to problem solving.
• Ability to handle and manage workload independently.

Education and/or Experience:

• bachelors Degree - Preferred: engineering, nursing, biomedical, life science, or equivalent (S.T.E.M.).
• Prior experience (2+ years) with PMS requirements (PMSP, PSUR) in medical device industry.
• Experience with current U.S. FDA, EUMDR, MDD, ISO 13485, ISO9001, MDSAP and/or CMDR regulations, standards, and guidance documents (Preferred).

Reasonable Accommodation