Coordinator, Regulatory Affairs Strategy

Based in the European HQ in Belgium, the Regulatory Affairs Strategy Coordinator reports to the Associate Director, Global Strategy & Implementation, Electrophysiology, Neurovascular, Aesthetics & Reconstruction and assists and supports the Electrophysiology, Neurovascular, Aesthetics & Reconstruction Regulatory Affairs Global Strategic Implementation Department in the execution of regulatory activities and organizational tasks.

In accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:

• Assists with organizational tasks for the Electrophysiology, Neurovascular, Aesthetics & Reconstruction Regulatory Affairs Global Strategic Implementation Department
• Prepares Departmental meetings and documentation for audits sessions (logistics, formatting, meeting minutes)
• Supports department PO’s, managing regulatory fees (Ariba).
• Acts as Records Management Coordinator, ensuring record retention policy and procedures are implemented
• 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:
• Conducts the necessary submission package for Certificate of Free Sales.
• 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.
• Assists with the preparation of responses to regulatory agencies questions and other correspondence.
• 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.
• Fulfills products distribution requests in accordance with Regulatory compliance status
• 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
• 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
• Performs other duties assigned as neededEXPERIENCE AND EDUCATION
• 0-2 years of work experience in Regulatory Affairs or Quality preferred. Candidates with
• University/Bachelors Degree or Equivalent

REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS*

• Excellent written and verbal communications skills in English (required)
• Creative and good computer skills: Pack Office, Outlook, OneNote, TEAMS
• Ability to execute with attention to details, meticulous, and applying Good Documentation Practices
• Ability to take on diverse tasks; executes under direction of an expert and offers insight.
• Ability to work in and with a diverse team
• Desire to learn and continuously improve
• Good organizational skills, project management methodology is a plus
• 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.

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