Regulatory Affairs Specialist - The Fountain Group

The Fountain Group is currently seeking a Regulatory Affairs Specialist for a prominent client of ours. This position is 100% REMOTE. Details for the position are as follows:

Job Description:

**REMOTE (CST Hours): Monday-Friday 1^st shift (8am-5pm or 7:30am-4:30pm)**

• The Regulatory Affairs Specialist coordinates, facilitates, and reports on post-market regulatory programs.
• Support the IA business units in meeting global registration requirements.
• As a regulatory process expert supporting global registrations the candidate interprets federal/state/international regulations as they apply to our products, processes and procedures, advises on impact of regulations, devises strategies for compliance, and liaison with regulatory bodies.
• Investigates and resolves compliance problems, questions and complaints.
• Ensures timely preparation of organized and scientifically valid reports both internally and externally
• Coordinates and manages the post-market regulatory reporting and compliance activities in accordance with Company procedures and regulatory requirements.
• Implements regulatory activities such as obtaining global regulatory clearances and/or approvals, preparing device listings, performing import/export requirements, fulfilling regulatory compliance obligations, and maintaining regulatory intelligence.
• Prepares and maintains regulatory licenses, reports, and listings.

Qualifications:

• BS/MS
• Regulatory Industry Experience (medical device)
  • Post-market activities
  • Any experience with recalls or other field actions
  • International registrations
  • Design and change evaluations
  • IVD/IVDR/MDR submissions or submission prep (in vitro / med dev regulations)

Compensation: Up to $31.93 per hour