Johnson & Johnson
BE - Clinical Complaints Analyst
Johnson & Johnson Worksense (via Randstad Sourceright) is responsible for finding, engaging and contracting talent for the Johnson & Johnson contingent workforce.
We are currently recruiting a Clinical Complaint Analyst to join our contingent workforce!
This position based in the European HQ in Diegem reports to the Sr Manager Quality EMEA.
The Clinical Complaints Analyst is responsible to maintain the quality processes associated with product complaint, vigilance and adverse event reporting procedures. The CCA ensures that European clinical complaints and adverse events from pre-and post- market studies are processed in accordance with established company procedures and applicable regulations and standards.
Do you have a degree in life science or nursing and are you interested in a cardiac medical devices? Then this might be the right position for you!
For this position we do not require relevant experience, only good motivation, interest in cardiac medical devices and the ability to start quickly!
Under limited supervision and in accordance with all applicable national laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:
- Establish standardized complaints handling process 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.
- Gain in-depth understanding of EP procedures and Biosense Webster devices.
- Gain 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.
- Facilitate follow-ups with International Technical Services, US complaints team, EMEA Clinical team, responsible manufacturers and Regulatory as needed.
- Function as primary contact for Affiliates by resolving issues, providing reports, training and other requests as needed.
- 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 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.
- Degree in science or nursing.
- A first experience within a regulated medical device/clinical environment is preferred. But we are also open for motivated juniors!
- Strong organizational skills.
- English proficiency oral and written. Ability to communicate with affiliate in additional languages is an asset.
- 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 understand and follow complex written procedures is required.
- Candidates should be familiar with general quality management system concepts, including good documentation practice (GDP), corrective and preventive action (CAPA), and document change control practices.
- Ability to function in a team environment and deliver on team objectives is required.
- Flexible working hours.
- Currently you will work remotely because of COVID-19. After COVID-19 you are expected to come on-site 3 days per week.
- This is a contracting position, with the possibility of an extension after the end date. You will receive a contract via our partner Ausy. Ausy can offer you a contract of indefinite duration or a project contract for the duration of the assignment at J&J.