To apply for multiple jobs at once, please select the check box beside the desired jobs on the main job category page.

Job #03522

About our client Our client is a leading global supplier of solutions for the biopharma, forensic and diagnostic industries The company is a leader in the development, production and distribution of advanced automation and detection solutions for the world’s leading life science laboratories Our client is a strong partner in laboratory automation Position Location Regional Regulatory Affairs Director Durham, NC Salary Highly competitive package, commensurate with experience Responsibilities 1) Manage Regulatory Affairs Specialists 2) Consult all relevant departments regarding regulatory affairs issues 3) Report all applicable adverse events to authorities 4) Define product classifications for defined markets 5) Perform internal training on regulations 6) Review customer contracts, advertising, promotional and labeling materials 7) Create and implements global procedures 8) Organize quarterly complaint meetings 9) Perform complaint reporting 10) Coordinate recalls and field corrections 11) Perform inter-company audits 12) Prepare product submissions 13) Evaluate applicable complaints for reportability 14) Review technical change requests 15) Administrate product declarations, certificates and related documents 16) Lead and support regulatory affairs projects 17) Handle essential tasks as assigned and respond to change productively 18) Follow all local safety procedures, State and Federal OSHA Regulations as well as report any safety concerns Requirements 1) Degree in Microbiology, Biochemistry, or Medical Science 2) Experience in quality assurance, process management, regulatory affairs 3) Experience in IVDD, MDD, or GMP environment 4) FDA/IVDD experience 5) Proficiency in English and German