Clinical Complaints Analyst
Locations: Diegem, Belgium
Functions: Quality (Generalist)
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Requisition ID: 1905764995W
ESSENTIAL DUTIES AND RESPONSIBILITIES
Under limited supervision and in accordance with all applicable national laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:
* Reviews Clinical Study safety management plans and protocols
* Develops in depth study knowledge
* Establish robust/ standardized complaints handling process at study launch
* Establish robust/ standardized documentation at study launch
* Investigates and develops solutions to procedure and process related issues.
* Reviews complaint documentation and obtains adequate information to ensure proper entry and validation of complaints.
* For marketed devices, ensures all applicable MDV regulatory reporting decisions, as required.
* For marketed devices, ensures all MDV regulatory reports are completed and reported according to regulatory requirements.
* Ensures the regulatory reporting of serious adverse events from pre-market studies are completed and reported according to regulatory requirements.
Possesses understanding of European medical devices vigilance regulations and keeps abreast of changes in the regulatory environment
* Possesses thorough understanding of complaint database.
* Develops, prepares and analyzes reports for complaints, as required.
* Requires in-depth understanding of EP procedures and Biosense Webster devices.
* Requires fundamental understanding of basic principles, theories, concepts and techniques related to customer complaints.
* May receive technical guidance on complex problems, but independently determines and develops approaches and solutions. Shares technical expertise with others and helps develop junior level analyst.
* Participate on project teams to improve department processes. May lead project teams.
* Conduct audit of complaint files and communicate results to appropriate individuals.
* Facilitate follow-ups with International Technical Services, US complaints team, EMEA Clinical team, responsible manufacturers and Regulatory as needed.
* Provide leadership that may include training, mentorship, and supervisory responsibilities as required.
* Function as primary contact for Affiliates by resolving issues, providing reports, training and other requests as needed.
* Issue and reviews requirements for database releases
* Assist in the execution and distribution of standard ad hoc reports.
* Sends closing letters
* Alert appropriate individuals when specific events or deviations in data are detected.
* Perform all duties and responsibilities in accordance with any professional requirements as well as those found in applicable policies and procedures and the Credo.
* Responsible for communicating business related issues or opportunities to next management level
* Responsible for ensuring subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition
* Responsible for ensuring personal and Company compliance with all National and Company regulations, policies, and procedures
* Performs other duties assigned as needed
REQUIRED EDUCATION/TRAINING and/or EXPERIENCE:
* BS/BA degree in business or science with 3 to 5 years experience within a regulated medical device/clinical environment; 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
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.
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
Johnson & Johnson Medical NV (7546)