What are the responsibilities and job description for the Regulatory Affairs Associate II position at BIOHORIZONS IMPLANT SYSTEMS?
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
- U.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
Benefits:
- 2 comprehensive medical plan options to choose from available the first of each month following your date of hire
- 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
Henry Schein, Inc. 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 is contingent upon the successful completion of a pre-employment background investigation to include a pre-employment drug screen.
