Regulatory Affairs Specialist

2 days ago

Birmingham, Alabama, United States BIOHORIZONS IMPLANT SYSTEMS Full time

Job Overview

BIOHORIZONS IMPLANT SYSTEMS seeks a highly skilled Regulatory Affairs Associate II to assist with the company's compliance with product registration requirements in international markets as well as compliance with Quality Systems regulations, standards, Good Manufacturing Practice and Good Documentation Practice.

 

Responsibilities
  • We are looking for someone who will adhere to the company's Quality Management System to ensure compliance with applicable regulatory requirements.
  • Maintain Company product registrations on a global basis, in compliance with U.S. FDA, EU MDD 93/42/EEC, Health Canada CMDR and other international regulations.
  • Maintenance of Company product registrations data for all global markets.
  • Assist other Regulatory Affairs personnel with international market regulatory activities as directed.
  • Research and report on adverse event reporting requirements, field correction notification requirements, market clearance requirements, etc.
  • Manage multiple establishment and product registration projects efficiently, effectively and concurrently.
  • Interact with multiple internal departments as well as international customers and regulators to complete assigned responsibilities.
Requirements
  • A Bachelor's Degree is required, preferably in a STEM program.
  • A Master's Degree is preferred.
  • 3+ years of experience in a U.S. FDA-regulated and registered medical device Manufacturer or Specification Developer environment in U.S. and foreign regulatory submissions are required.
  • Experience with 510(k) FDA submissions is preferred.
  • Complaints Management, MDR Reporting, CAPA administration, Auditing experience is preferred.
  • U.S. RAPS Regulatory Affairs Certification is preferred.
  • ASQ certification in Quality Manager, Engineer, or Auditor is desired.
  • Strong attention to detail is required.
  • Excellent organizational, interpersonal, written, and verbal skills are required.
  • Demonstrated problem-solving skills are required.
  • The ability to work and communicate effectively with others is required.
  • Experience with MS Office suite is required.
Benefits
  • Two comprehensive medical plan options are available the first of each month following your date of hire.
  • Flexible Spending Account or HSA Account is available.
  • Vision Benefits are available.
  • Company-paid Dental Insurance for employee and dependents is available.
  • A Wellness Plan is available.
  • A 401k with 5% matching is available.
  • A Generous PTO plan including 11 paid holidays, 2 Floating Holidays, and Community Service Hours is available.
  • Company-paid Short Term Disability is available.
  • Long Term Disability is available.
  • Company-provided Life Insurance is available.
  • Paid Parental Leave is available.
  • Casual Dress Code is available.
  • Social events for employees and family are available.

BIOHORIZONS IMPLANT SYSTEMS is an Equal Employment Opportunity Employer and does not discriminate against applicants or employees on the basis of race, color, religion, creed, national origin, ancestry, disability that can be reasonably accommodated without undue hardship, sex, sexual orientation, gender identity, age, citizenship, marital or veteran status, or any other legally protected status.

Please note that any offer of employment made by BIOHORIZONS IMPLANT SYSTEMS is contingent upon the successful completion of a pre-employment background investigation to include a pre-employment drug screen.

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