Our client is presently looking for a Regulatory Affairs Specialist to join their Regulatory Affairs Team. The person chosen for this position will be responsible for coordinating activities related to product & system compliance and managing international product submissions and approvals. This person will need to stay abreast of regulations, work directly with regulatory bodies, distributors and others throughout the world to obtain product approvals. This position will maintain regulatory agency and product technical files and serve as a Regulatory Affairs Representative on multiple product teams. Other regulatory duties to be assigned. 



Required qualifications are: 



• Bachelor’s Degree in a scientific/engineering discipline and five or more years of medical regulatory experience
• Five years experience with national and international product regulations, laws and standards
• Key attention to detail and organizational skills
• Ability to work independently

Preferred qualifications:

• Experience and knowledge of the European Medical Device Directive and CE marking process 


• Regulatory Affairs Certification (RAC) 


• Experience working in varied cultural environments