BE - Regulatory Affairs Officer

Johnson & Johnson Worksense (via Randstad Sourceright) is responsible for finding, engaging and contracting talent for the Johnson & Johnson contingent workforce.

The Regulatory Affairs Coordinator reports to the CSS Regulatory Affairs Manager, Strategic Programs, EU MDR.

This position assists and supports the CSS Regulatory Affairs, Global Strategic Implementation Department in the execution of regulatory activities for Medical Devices of J&J.

DUTIES & RESPONSIBILITIES

• Technical Dossier analysis of feedback provided to Notified Bodies and Questions received from Notified Bodies.
• Assists and supports the team members in the execution of regulatory strategies impacting all CSS for MDR Implementation and Execution.
• Gathers and assembles data necessary for the development of the regulatory aspects of project plans including tracking, planning and communication.
• Assists in the execution of regulatory strategies for non-EU countries, including coordinating and tracking document requests.
• Creates and approves ECO’s pertaining to the Coordinator’s projects and duties (including but not limited to SOPs, EU labeling approval).
• Responsible for administrative tasks to support the CSS MDR activities including preparation of meetings and general administrative activities.
• Responsible for compiling reports, presentations and creating flowcharts.
• Researches, collects, cross-check data from different sources, and responds to requests from internal colleagues.
• 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.
• Performs other duties assigned as needed.

EXPERIENCE AND EDUCATION

• A university, bachelor’s degree or equivalent,
• 0-2 years of work experience, preferably but not limited to regulatory affairs. (Technical File/Design Dossier/Technical Dossier preparations or submissions).

REQUIRED KNOWLEDGE & SKILLS

• Good command of database and spreadsheet software.
• Excellent written and verbal communication skills in English.
• Creative and advanced computer skills: Excel (mandatory), Power Point, One Note, Microsoft Team.
• Analytical, self-motivated, energetic, well organized, and self-disciplined person.
• Attention to detail.
• Capacity to work autonomously,.
• Ability to take on diverse tasks, good organizational skills.

EXTRA INFORMATION:

• Flexible working hours.
• Because of COVID-19, you will work fulltime from home.
• This is a long term contracting position, with the possibility of an extension after the end date. You wil receive a contract via our partner Randstad Professionals. They can offer you a contract of indefinite duration, a project contract for the duration of the assignment at J&J or a freelance contract.