Regulatory Compliance Specialist

12 hours ago


Birmingham, Alabama, United States BIOHORIZONS IMPLANT SYSTEMS Full time

BioHorizons Implant Systems is seeking a highly motivated Regulatory Compliance Specialist to join their team in Birmingham, AL. The ideal candidate will possess a strong understanding of regulatory affairs and compliance within the medical device industry.

Job Overview

The Regulatory Compliance Specialist will be responsible for ensuring compliance with FDA establishment registrations, medical device listings, and state Board of Pharmacy regulations. This role will also involve acting as a regulatory liaison for the entire product lifecycle, participating in product registration activities, and maintaining company product registrations data.

The successful candidate will have a 4-year undergraduate degree in a science-related field and up to three years of experience in a medical device or similarly regulated industry. A basic knowledge of QMS requirements and design control principles is desired.

Responsibilities
  • Maintain accurate and up-to-date records of FDA establishment registrations and medical device listings
  • Evaluate and ensure compliance with state Board of Pharmacy and tissue banking regulations
  • Act as regulatory liaison for the entire product lifecycle, including dental implants, tools, and accessories
  • Participate in product registration activities for US FDA, European, and international markets
  • Conduct complaint investigations and support overall complaint management
Requirements
  • 4-year undergraduate degree in a science-related field
  • Up to three years of experience in a medical device or similarly regulated industry
  • Basic knowledge of QMS requirements and design control principles
Benefits
  • Estimated Salary: $65,000 - $80,000 per year
  • 2 comprehensive medical plan options to choose from
  • Flexible Spending Account or HSA Account available
  • Vision Benefits
  • Company-paid Dental Insurance for employee and dependents
  • Wellness Plan
  • 401k with 5% matching
  • Generous PTO plan including 11 paid holidays, 2 Floating Holidays, and Community Service Hours
  • Company-paid Short Term Disability
  • Long Term Disability
  • Company-provided Life Insurance
  • Paid Parental Leave
  • Casual Dress Code
  • Social events for employees and family


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