Vigilance specialist - complaint analyst (Biosense Webster EMEA)
Locations: Diegem, Belgium
Functions: Customer Technical Service
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Requisition ID: 1905734611W
This position is based in the European HQ in Belgium. The Complaint Analyst is responsible to process EMEA complaints and vigilance 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. The Complaint Analyst reports directly to the Sr Manager Quality EMEA.
DUTIES & 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, as required.
* Ensures all MDV regulatory reports are completed and reported according to regulatory requirements.
* Possesses understanding of European medical devices regulations and keeps abreast of changes inthe regulatory environment
* Possesses thorough understanding of complaint database.
* Develops, prepares and analyzes trend reports for complaints, as required.
* Requires fundamental unders tanding of basic principles, theories, concepts and techniques related to customer complaints.
* Facilitates follow-ups with International Technical Services, US complaints team, EMEA Clinical team, responsible manufacturers and Regulatory as needed. Responds back to field representatives and EMEA affiliates offices within 1 business day in response to email or voice mail messages.
* Composes customer or affiliate complaint investigation responses.
* Supports Field Action coordinator in Field Action management
* Supports product rework at EDC as needed
* Supports Stop Shipment process as needed
* Inspects returned products at EDC
* Supports Clinical Department for Adverse Event reconciliation
* 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
EXTERNAL AND INTERNAL INTERACTIONS
For complaint investigation purpose and Regulatory decision, the Complaints Analyst will interact mostly with J&J EMEA affiliates, BW EMEA field persons, International Technical Services, US complaints team, Clinical Safety department, EMEA Clinical team, responsible manufacturers, National Competent Authorities and Regulatory as needed.
Company management reserves the right to add, delete or otherwise alter assigned duties at any time. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The minimum qualifications listed are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
REQUIRED EDUCATION/TRAINING and/or EXPERIENCE:
* QUALIFICATION REQUIREMENTS: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.
* EDUCATION and/or EXPERIENCE: BS/BA degree in science/ health with at least 3 years' experience within a quality or regulatory environment; or a similar experience within a regulated industry; or equivalent combination of education and experience.
REQUIRED KNOWLEDGE, SKILLS, ABILITIES and CERTIFICATIONS/LICENSES:
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; including:
* Communication - written & verbal in a clear, concise & effective manner.
* Interpersonal skills - interact with all levels, personalities, cultures & disciplines of organization to produce required results.
* Investigative & analytical - to establish possible options for action.
* Results oriented - in a fast-paced environment.
* Leadership skills.
* Project management - in an environment with multiple tasks & tight timeframes.
* Knowledge of applicable quality, CE mark (Medical Device Directive) & ISO (International Organization for Standardization) requirements
* Customer focus.
* Clinical expertise.
ADDITIONAL POSITION REQUIREMENTS
Occasional travel will be required. This job description is an outline of the major recurring responsibilities of the job. It is not intended to be all inclusive of the work to be performed. The incumbent(s) will typically perform other related job objectives, special assignments and less significant responsibilities.
Johnson & Johnson Medical NV (7546)
Customer Technical Service