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Regulatory Affairs Coordinator

Summary: Provides regulatory support to internal instrument development, and the regulatory aspects of bringing instruments to market and distribution.

Essential Duties and Responsibilities:
  • Works with internal teams and outside vendors to process CFGs/Apostilles and regulatory submissions.
  • Assists with assembling documentation to support worldwide registrations.
  • Performs research necessary to assist customers in registration of their surgical instruments.
  • Maintains current revision of all package labels and IFUs including processing and sending for approval, managing revisions, proofreading.
  • Investigates/analyzes and supports customer quality concerns.
  • Performs general regulatory administrative tasks such as scanning, filing, supplies, shipping, document organization.
  • Performs file searches and maintains files in electronic document management system.
  • Accurately and timely completes required paperwork, documentation, and records.
  • Maintains professional working relationships and effectively communicates with all employees, managers, vendors, customers, distributors and regulatory agencies.
  • Understands, complies with and supports company policies and procedures, regulatory requirements and safety regulations/initiatives.
  • Regular attendance at work is required.
  • Performs other assignments as necessary.

Qualifications:
  • Requires a Bachelor’s Degree or Certificate of equivalent course study in a related field, and/or 5 years of experience in Regulatory Affairs relating to Medical Devices preferred; or equivalent combination of education and experience.
  • Knowledge of FDA design control activities and design history files, determining Medical Device Classifications (FDA and EU), registering devices, generating and checking technical documentation such as Technical Files, FMEAs, design drawings, risk analysis preferred.
  • Requires excellent organizational, interpersonal, technical writing, presentation and communication skills.