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Sr Executive, Product Surveillance

Sr Executive, Product Surveillance

Vantive

2 - 7 years

4 - 7 Lacs

gurugram

Posted:-1 days ago| Platform:

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Skills Required

product quality nursing iso 13485 analytical trend analysis system software ms office biomedical quality compliance recruitment

Work Mode

Work from Office

Job Type

Full Time

Job Description

Essential Duties and Responsibilities:

Evaluate potential product quality complaints and initiate applicable records actions within proper Quality System.

Own and process quality complaint as per applicable procedures.

Determine, facilitate and/or approves reportability assessments and decisions based on applicable procedures.

Author and submit applicable regulatory reports (MDR, MIR, etc.) to competent authorities when deemed required.

Monitor the status and progression of complaints under investigation and initiate actions to facilitate its resolution and closure.

Review and approve the results of Engineering, Manufacturing, Quality, Service and/or Supplier evaluations and investigations of complaints.

Performs queries to provide complaint data and ad hoc trend analysis on reported product problems/complaints to drive continuous improvements within the department and organization.

Implement and maintain Post Market Surveillance documents (PMSP, PSUR, etc.) as per EU Medical Device Regulation.

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.

Well organized and able to multitask effectively in a rapid paced environment, as well as show assertiveness, when interfacing with other personnel during the complaint handling process.

Experience with Trackwise or equivalent complaint tracking system software and Microsoft Office and database skills are required.

Knowledge of FDA/ ISO regulations and Country requirements.

Knowledge of MDR and MDV reporting.

Education and/or Experience:

Bachelor s Degree - Preferred: engineering, nursing, biomedical, life science, or equivalent (S.T.E.M.).

Prior experience (2+ years) with Regulatory, Quality, Compliance or a combination of technical experience such as analytical development, manufacturing sciences and Quality/Regulatory.

Experience with current U.S. FDA, EUMDR, MDD, ISO 13485, ISO9001, MDSAP and/or CMDR regulations, standards, and guidance documents (Preferred).

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Sr Executive, Product Surveillance