Complaint Analyst EMEA-00000JDB
Description
We are currently recruiting for a :
Complaints Analyst EMEA
This position is based in the European HQ in Belgium. The Complaints Analyst is responsible to process EMEA complaints in accordance with established company procedures and applicable regulations and standards. The position is responsible to maintain a high level of customer satisfaction and responsiveness to internal and external customers, affiliates as well as EMEA regulatory bodies with regard to product complaints or inquiries.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Under minimal supervision and in accordance with all applicable national laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:
– Reviews complaint documentation and obtains adequate information to ensure proper entry and validation of complaints, as back up for Juarez Complaint team.
– Ensures all applicable MDV regulatory reporting decisions, with the support of the Senior Complaint Analyst, as required.
– Ensures all MDV regulatory reports are completed and reported according to regulatory requirements.
– Possess understanding of European medical devices regulations and keeps abreast of changes in the regulatory environment
– Possess thorough understanding of complaint database.
– Develops, prepares and analyzes trend reports for complaints, as required.
– Requires fundamental understanding of basic principles, theories, concepts and techniques related to customer complaints.
– Facilitate follow-ups with International Technical Services, US complaints team, EMEA Clinical team, responsible manufacturers and Regulatory as needed.
– Issues closing letters to affiliates when product analysis has been performed.
– Responds back to field representatives and EMEA affiliates offices within 1 business day in response to fax, email or voice mail messages.
– Compose customer or affiliate complaint investigation responses.
– Alerts supervisor as appropriate of critical communication from customers.
– Maintains knowledge of Biosense Webster products and their use.
– Documents all information according to Biosense Webster policy and EMEA regulatory standards
– Educates field sales force and affiliates in utilization of complaints department for reporting of field complaints
– Participate on project teams to improve department processes.
– Responsible for ensuring personal and company compliance with all local and company regulations, policies and procedures
– Responsible for communicating business related issues or opportunities to next management level
– Responsible for ensuring personal and Company compliance with all National and Company regulations, policies, and procedures
– Perform all duties and responsibilities in accordance with any professional requirements as well as those found in applicable policies and procedures and the Credo
– Performs other duties assigned as needed
Qualifications
– BS degree in science with 2-3 years experience within a regulated medical device/clinical environment preferred; or equivalent combination of education and experience.
– English proficiency oral and written
– Must have adequate computer skills to evaluate trending data, complete regulatory reports, and provide written correspondence to internal and external customers including regulatory bodies as appropriate.
– Ability to communicate with affiliate in additional languages is an asset.
– Ability to use computers and computer based software.
– Ability to read and interpretate documents such as safety rules, operating and maintenance instructions, and procedure manuals.
– Occasional travel will be required.
Primary Location:Europe/Middle East/Africa-Belgium-Brussels-Capital Region-Diegem
Organization: Johnson & Johnson Medical NV (7546)
Job Function: Quality (Generalist)