Looking for a Regulatory Affairs Coordinator to join the European HQ in Belgium for our leading client in Pharma! You will be assisting and supporting the CSS Regulatory Affairs Global Strategic Implementation Department in the execution of regulatory activities and organizational tasks.
· Assists with organizational tasks for the CSS 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
· Creates/revises quality systems documents (including but not limited to Change Orders on SOPs)
· Conducts searches of existing files for requested information. Liaises with the manufacturer to obtain all necessary documents and prepares regulatory documentation for submissions/registrations.
· Assists with the preparation of responses to regulatory agencies questions and other correspondence.
· Maintains regulatory databases, trackers and systems
· 0-2 years of work experience, experience in Regulatory Affairs or Quality Affairs preferred.
· University/Bachelors Degree or Equivalent
· Creative and good computer skills: Pack Office, Outlook, OneNote, TEAMS
· Ability to execute with attention to details, meticulous, and applying Good Documentation Practices
· Preferred: knowledge of medical device regulatory requirements in the EU, Quality Management Systems and experience in the Medical Device industry or medical field
· Start date: ASAP
· Location: Diegem, Leonardo Da Vincilaan 15
· Full- time, hybrid: 3 days on site, 2 off site
· Contract: 1 year
Get in touch ASAP by sending your CV to firstname.lastname@example.org or call me on +31202044502! You can also refer a friend and both earn 250 Euros on placement.