This position is a divisional role and one of the Regulatory Affairs (RA) core team members supporting both manufactured and OEM laboratory equipment products for the Laboratory Equipment Laboratory Product Division (LPD). The Post Market arm of Regulatory Affairs is responsible for receiving, reviewing and processing product inquires and product complaints for manufactured and distributed products as required by applicable regulations, standards, and company policy. This position will liaison between manufacturing facilities, distribution centers, customer/technical service and customers regarding product complaints. In addition, this position will partner with Operations Quality on any possible adverse event (MDR/MDV), reportable complaints, new product failure modes or adverse complaint trends.
- 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.
- Education: B.S./B.A in technical or business related field; advanced degree a plus
- Five or more years of experience in Quality/Regulatory compliance (three years with an advanced degree), experience working in a matrix organizational structure a plus.
- Working knowledge of the application of FDA and ISO quality standards in industry.
- Experience with FDA or Notified Body inspections.
- Experience in Post Market Surveillance Activities (MDR/MDV submissions, Recalls etc.).
- Solid knowledge of the applicable safety standards and how to apply them effectively.
- Direct interface with competent authorities or regulatory bodies a plus.
- Medical Device or Pharmaceutical manufacturing experience preferable.
- Adaptability and flexibility to manage changing demands and handle substantial time pressures
- Demonstrated experience in problem solving and assessing risks around a product liability issue.
- Position requires up to 10% overnight and international travel. Required travel may span weekend days and/or holidays. Must have or be able to obtain a valid passport which allows travel to countries in Europe, N. America and S. America and Asia Pacific as required. Requires ability to transport and use common computer and communications equipment while traveling.