RA Post Market Specialist
Job ID :
India - Hyderabad
- Developing professional expertise, applies company policies and procedures to resolve a variety of issues.
- Interfaces with Customer Service, Sales Representative and Customers to gather additional information required for complaint initiation/investigations, including the retrieval of product samples and or durable equipment retrieval for evaluation.
- Ensures that complaints from multiple sources (i.e. verbal, email, fax, etc.) are entered into the complaint database.
- Responsible for receiving, reviewing, and entering data into the Compliant Management Database regarding customer product inquiries and complaints using good documentation practices (GDP).
- Works on problems of moderate scope where analysis of situation or data requires a review of a variety of factors. Exercises judgment within defined procedures and practices to determine appropriate action.
- Ensures that equipment technical service reports and Sales Force cases are correctly evaluated for potential complaints and, where applicable, processed accordingly.
- Determines complaint problem and fix codes based on the master code list.
- Applies knowledge of device regulatory requirements in order to support the Post Market Surveillance MDR/MDV reporting process and evaluates complaints for reporting utilizing product knowledge and decision trees.
- Prepares customer communication (response letters, acknowledgement letters) as appropriate.
- Partners with Sales, Marketing, Quality and Manufacturing departments to resolve product problems and provides feedback to customers as needed.
- Assists with review of the timely coding of completed investigations, closure of all complaint files, and ensures that all pertinent information is contained consistently and uniformly within the file prior to closure.
- Performs queries to provide complaint data and ad hoc trend analysis on reported product problems/complaints.
- Interfaces with Operations Quality at manufacturing sites as required for product investigations/trends.
- Adheres to all regulatory and division/company policy requirements.
- Ensures data is collected through routine business processes and reviewed for accuracy, timeliness, relevance, completeness, understood by users, and quality.
- Builds productive working relationships.
- Escalates issues to supervisor/manager for resolution, as deemed necessary.
- Reviews and complies with the Code of Business Conduct and all applicable company policies and procedures, local, state, and federal laws and regulations.
- Other duties as assigned.