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 requirementsMaintain Company product registrations on a global basis, in compliance with U.S. FDA, EU MDD 93/42/EEC, Health Canada CMDR and other international regulationsMaintenance of Company product registrations data for all global marketsAssist other Regulatory Affairs personnel with international market regulatory activities as directedResearch and report on adverse event reporting requirements, field correction notification requirements, market clearance requirements, etcManage multiple establishment and product registration projects efficiently, effectively and concurrentlyInteract 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 programMaster’s Degree preferred3+ years’ experience in a U.S. FDA-regulated and registered medical device Manufacturer or Specification Developer environment in U.S. and foreign regulatory submissions requiredExperience with 510(k) FDA submissions preferredComplaints Management, MDR Reporting, CAPA administration, Auditing experience preferredU.S. RAPS Regulatory Affairs Certification preferredASQ certification in Quality Manager, Engineer, or Auditor desiredStrong attention to detail requiredExcellent organizational, interpersonal, written, and verbal skillsDemonstrated problem-solving skillsMust have the ability to work and communicate effectively with othersExperience with MS Office suite required

 

Benefits:

 

2 comprehensive medical plan options to choose from available the first of each month following your date of hireFlexible Spending Account or HSA Account availableVision BenefitsCompany paid Dental Insurance for employee and dependentsWellness Plan401k with 5% matchingGenerous PTO plan including 11 paid holidays, 2 Floating Holidays and Community Service HoursCompany paid Short Term DisabilityLong Term DisabilityCompany provided Life InsurancePaid Parental LeaveCasual Dress CodeSocial 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.