BE - Vigilance Specialist - Complaint Analyst EMEA

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 Vigilance Specialist / Complaint Analyst to join our contingent workforce!

This position is based in the European HQ in Belgium. The Vigilance Specialist 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.

Do you have a degree in life science or nursing and are you interested in 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!

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 in the regulatory environment.
• Possesses 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.
• 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. 100612422 Rev 4 CONFIDENTIAL use pursuant to Company Procedures Page 3 of 5.
• 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 the Clinical Department for Adverse Event reconciliation.
• Ensures the regulatory reporting of serious adverse events from pre-market studies are completed and reported according to regulatory requirements.
• Alerts supervisor as appropriate for 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.
• Participates 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 the next management level.
• Responsible for ensuring personal and Company compliance with all National and Company regulations, policies, and procedures.
• Performs 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.

Requirements:

• Degree in life science or medical related.
• A first experience within a regulated medical device/clinical environment is preferred. But we are also open for motivated juniors!
• Strong organizational skills and proactive mindset.
• English proficiency oral and written. Ability to communicate in additional languages is an asset.
• 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 use computers and computer based software.
• Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.

EXTRA INFORMATION:

• 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.