#2506230316W
artment PO's, managing regulatory fees (Ariba).
o Acts as Records Management Coordinator, ensuring record retention policy and procedures are implemented
o Administers the updating of regulatory processes, work instructions, training materials, and filing registrations to support Regulatory Affairs quality systems documents (including but not limited to Change Orders on SOPs)
Helps coordinate the preparation, delivery, archiving, and tracking of regulatory activities:
o Conducts the necessary submission package for Certificate of Free Sales.
o Organizes partnerships with the manufacturer to research, gather, prepare, and archive regulatory information necessary for submissions/registrations. Conducts searches of existing files for requested information.
o Assists with the preparation of responses to regulatory agencies questions and other correspondence.
o Codes, retrieves, and reports on data from Regulatory Affairs and related databases tracker and system to ensure prompt and accurate access to company regulatory information.
o Fulfills products distribution requests in accordance with Regulatory compliance status
o Conducts the execution of product labeling customization activities
Assists in the development of best practices for Regulatory Affairs processes
Provides solutions to a variety of problems of limited scope and complexity
o Responsible for communicating business related issues or opportunities to next management level
o Responsible for following all Company guidelines related to Health, Safety and Environmental practices as applicable.
o 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
o Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
o Performs other duties assigned as needed
Qualifications
EXPERIENCE AND EDUCATION
o 0-2 years of work experience in Regulatory Affairs or Quality preferred. Candidates with < 2 years of practical experience who currently possess an advanced degree will also be considered.
o University/Bachelors Degree or Equivalent
REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS*
o Excellent written and verbal communications skills in English (required) and French OR Dutch
o Creative and good computer skills: Pack Office, Outlook, OneNote, TEAMS
o Ability to execute with attention to details, meticulous, and applying Good Documentation Practices
o Ability to take on diverse tasks; executes under direction of an expert and offers insight.
o Ability to work in and with a diverse team
o Desire to learn and continuously improve
o Good organizational skills, project management methodology is a plus
o Preferred: knowledge of medical device regulatory requirements in the EU, Quality Management Systems and experience in the Medical Device industry or medical field
Reports to the Associate Director Regulatory Affairs Strategy
No direct or indirect reports
Interaction with Electrophysiology, Neurovascular, Aesthetics & Reconstruction Global Strategic Implementation team, Regulatory Affairs counterparts cross franchise, Manufacturers, Johnson & Johnson local regulatory affiliates, quality department, technical department, finance and human resources, Regulatory Policy, medical sciences, and various working groups.
For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world's most pressing healthcare challenges.
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