Senior Health Authority Reporting Analyst

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

• Demonstrate world-class customer support and maintain knowledge of relevant Operating Company’s products and services.
• • Assess, process, and close complaint files within scope of internally and externally manufactured products in accordance with associated complaint handling procedures and CQ expectations. This may include assigning product experience and patient codes. Utilize MD Workflow reports to identify tasks and manage common Email inboxes.
• • Make regulatory reporting determinations on applicable files for one or more Business Units. Execute file reviews, making and/or reassessing MDR and/or MDV decisions and managing relevant complaint file activities.
• • File Medwatch report forms within required timelines as applicable.
• • File MDVs in accordance with EEA, Switzerland and Turkey, candidate countries and other third countries guidelines within the required timelines as applicable.
• • Create and/or forward additional information, follow up questions as part of complaint investigation. Assign the appropriate complaint system activities to other sites to ensure timely execution of complaint investigation and complaint file management
• • Appropriately utilize risk management documentation to support the complaint’s regulatory reporting process o Involved in the maintenance of the Reportable Malfunction List and regulatory reporting tables in support of complaint management database activities as applicable.
• • Manage Standard and non-Standard Health Authority Requests of Health Authorities incl. justifications for non-reporting in accordance with FDA and EU regulations as applicable.
• • Lead support for regulatory additional information requests and actively support compliance audits.
• • Lead/ support audit and compliance review processes as needed
• Maintain a full understanding of current Customer Quality and other independent quality system policies and procedures.
• • Lead assigned projects towards desired business outcomes.
• • Lead the onboarding training of new associates and/or existing associates learning a new product.
• • Lead in escalation process as required.
• • Partner with and influence stakeholders both internally and externally to drive needed change and/or execution of complaint related matters
• • Responsible for communicating business-related issues or opportunities to next management level
• • Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
• • For those who supervise or manage a staff, responsible for ensuring that 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, if applicable
• • Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures

• Completed apprenticeship or bachelor's degree, preferably Scientific, Medical, Life Science, Health Science, Technical, or Engineering field or University/bachelor’s degree or equivalent experience.
• • 2-4 Years related experience is desirable (A combination of experience and education can be allowed)
• • Knowledge of applicable quality, FDA (Food & Drug Administration); Medical Device Directives/ Regulation & ISO (International Organization for Standardization) requirements
• • Knowledge of human anatomy, medical terminology and products of applicable Business Units
• Strong written and verbal communication skills. Fluent English speaker with written English to B2 standard.
• • Strong decision-making skills – able to make sound business decisions with sometimes limited information
• • Ability to work in a cross-functional and matrix environment
• • Ability to work independently
• • Continuous Improvement focus
• • Time management
• • Ability to handle multiple priorities/ sudden changes in priorities
• • Strong attention to detai