Regulatory Affairs Administrator

CEFALY is a MedTech device company looking for a Regulatory Affairs Administrator. This role will be responsible for determining and supporting the regulatory activities to maintain regulatory compliance for our D2C MedTech products globally. The RA Administrator is also required to provide general administrative support to Quality and Regulatory group.

This position will be based in the Darien, CT office

PRINCIPAL RESPONSIBILITIES :
Assist Regulatory Affairs Function, through the following activities, as required:

  • Process Global Regulatory Requests through the appropriate processes and systems
  • Maintain product listings including FURLS, HPRA etc.
  • Manage requests and tracking of CFG applications and invoices
  • Coordination of documents and invoices
  • Support process improvements projects for regulatory operations
  • Update and provide metrics on licenses and approvals as required
  • Support with QMS change control activities
  • Liaise with various regulatory affairs departments to ensure correct supporting data is provided in a timely manner to requests
  • Maintain regulatory database (RAMS) with all current and expired registrations
  • Provide administrative support to Quality and Regulatory team


EDUCATION / EXPERIENCE REQUIREMENTS :

  • 1+ years experience in Quality or Regulatory Affairs
  • High attention to detail and accuracy
  • Excellent organizational and communication skills
  • Fluent English, both written and oral. *French a plus
  • Ability to work well under deadlines and pressure
  • Knowledge of electronic document management systems and computer office applications.
  • The ability to prioritize tasks and manage several projects and tasks simultaneously


SPECIALIZED SKILLS & OTHER REQUIREMENTS : (Preferred)

  • Understanding of domestic and international medical device regulations
  • Must have experience working for a medical device company, direct to consumer preferred.