BE - Regulatory Affairs Support Specialist

Based in the European HQ in Belgium, the Regulatory Affairs Support Specialist assists and supports the CSS Regulatory Affairs Global Strategic Implementation Department in the execution of regulatory activities and organizational tasks. Responsible for supporting the Regulatory Affairs Global Strategic Implementation Department in the execution of regulatory activities and organizational tasks.

WILL BE EXTENDED UNTIL THE END OF 2021.

MAIN TASKS:

• Assists with organizational tasks for the CSS (cardiovascular & specialty solutions) Regulatory Affairs Global Strategic Implementation Department.
• Responsible for the maintenance of regulatory databases, trackers and systems.
• Assists with preparing the necessary documents, outlines and application forms for initial clinical study regulatory submissions, amendments, and closure of study packages in compliance with country regulatory requirements.
• Prepares Departmental meetings and audits (logistics, formatting). 
• Ensures payment administration in Ariba.
• Coordination of training into the Learning Management System (Compliance Wire).
• Acts as Records Management Coordinator, ensuring record retention policy and procedures are implemented.
• Creates and approves ECOs pertaining to the Coordinator’s projects and duties (including but not limited to SOPs).
• Fulfills products release requests in accordance with Regulatory requirements (Item restriction Process).
• Fulfills Late Stage Customization (LSC) preparation, update, implementation of the Product Artwork Relationship Matrix (PARM).
• Provides operational support for affiliates requests.
• Provides operational support for economic operator and supply chain initiatives for CSS, including but not limited to those for European Authorized Representative.
• 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.
• 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.
• Organizes and updates regulatory compliance documents and databases.
• Maintains database index of regulatory information regarding company products.
• Compiles compliance information, provides routine and non-routine regulatory reports as requested, and keeps regulatory listings current.
• Participates in compliance activities and responds to moderately complex compliance queries.
• Reviews industry standards and regulations to identify inconsistencies with policies and procedures that may require revision.
• Notifies key stakeholders of audit schedule and changes.
• Provides general administrative support as directed. (Example: create a Power Point presentation for professional purposes.)
• Supporting routine RA activities.
• Performs other duties assigned as needed.

EXPERIENCE, KNOWLEDGE & SKILLS:

• Minimum 1 year of work experience within Regulatory Affairs or Quality Assurance preferably in Medical Devices or the Pharmaceutical industry.
• Experience with supporting registrations for international markets is an asset.
• Excellent written and verbal communication skills in English. (Knowledge of Dutch or French is an asset but not required.)
• Creative and good computer skills: Outlook, Power Point, One Note, Excel.
• You are detail oriented and conscientious.
• Ability to take on diverse tasks as you will support RA Managers and departments.

EXTRA INFORMATION:

• Flexible working hours.
• You will work closely with J&J sites in the US. (9 hour time difference)
• Currently you will work remotely because of COVID-19.
• After COVID-19 you are expected on site at least 3 days a week.

Note: This is a contracting position, with the possibility of an extension after the end date. You wil receive a contract via our partner Ausy. Ausy can offer you a contract of indefinite duration, a project contract for the duration of the assignment at J&J or a freelance contract.