Regulatory Affairs Specialist

The Regulatory Affairs (RA) Specialist is responsible for supporting the Regulatory Affairs department in global submissions, registrations, approvals, and audits; especially as it relates to footprints projects and sustaining activities. This is a great learning opportunity for someone interested in a Regulatory Affairs career in medical devices. Will train an enthusiastic, eager learner with a team attitude and passion for medical devices and helping patients thrive.

PRIMARY DUTIES & RESPONSIBILITIES:

• Supports footprints projects with the ability to multi-task
• Assembles and submits documents for global registrations with direct oversight from the RA team
• Ensures all deadlines are met, paying particular attention to any government deadlines
• Collaborates with other departments to gather documentation needed for global submissions
• Responds effectively and timely to internal and external partners
• Tracks submissions and maintains applicable dashboards
• Prepares weekly reports on status of current items/issues to manager
• Organizes and maintains files, folders and databases to support the integrity of regulatory documentation
• Orders documents, subscriptions, articles, standards and other items; including Free Sale Certificates and Certificates to Foreign Government
• Coordinates audits as needed
• Coordinates notarization and authentication (legalization) of documents
• Coordinates shipment of documents (UPS, etc) and may also be responsible in coordinating samples
• Prepares data for audits, as needed
• Reviews publications to keep abreast of regulatory landscape for medical devices
• Performs special projects at the direction of the Regulatory Affairs Management
• May assist in the regulatory review of product claims and literature

Job Requirements:

REQUIREMENTS:

• bachelors degree in a related field plus 2 years of relevant work experience required, preferably in the Medical Device or Pharmaceutical industry or technical field.