Career Center

The Regulatory Affairs Associate II will assist with the companies compliance with product registration requirements in international markets as well as compliance with Quality Systems regulations,  standards, Good Manufacturing Practice and Good Documentation Practice.  The ideal candidate must live in Birmingham, Al. 

The responsibilities of this position include, but may not be limited to the following:

• 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

The ideal candidate for this position will possess the following qualifications:

• Bachelor’s Degree required, preferably in a STEM program
• Master’s Degree preferred
• 3+ years’ experience in a U.S. FDA-regulated and registered medical device Manufacturer or Specification Developer environment in U.S. and foreign regulatory submissions required
• Experience with 510(k) FDA submissions preferred
• Complaints Management, MDR Reporting, CAPA administration, Auditing experience preferred
• S. RAPS Regulatory Affairs Certification preferred
• ASQ certification in Quality Manager, Engineer, or Auditor desired
• Strong attention to detail required
• Excellent organizational, interpersonal, written, and verbal skills
• Demonstrated problem-solving skills
• Must have the ability to work and communicate effectively with others
• Experience with MS Office suite required

About BioHorizons

BioHorizons is a leader in advanced dental implant technologies and tissue regeneration products in the dental implant industry. The company, headquartered in Birmingham, Alabama, offers a broad spectrum of products for the replacement of missing teeth including dental implants, guided surgery, restorative components, and bone and soft tissue biologic products. BioHorizons' innovative dental implant designs are recognized for intuitive design, excellent primary stability, and high-end, esthetic results for patients. BioHorizons products are available in 90 countries around the world. For more information, visit biohorizons.com.

Connections working at BioHorizons