Senior Quality Assurance and Regulatory Affairs Analyst

Qualifications Required:
a) Education:  
Bachelor’s degree in related discipline
 
b) Experience:  
 Minimum 4 years in a medical device, life sciences or similar industry.  
Experience in a software development industry preferable.  
Experience in performing internal/external/supplier audits preferable.    
 
c) Background:
 Working knowledge of medical device regulations and standards applicable to IWCS products, including:
ISO 13485 Medical Device Quality System Requirements,  ISO 14971 Medical Device Risk Management  FDA Quality System Regulation (21 CFR 820)  Canadian Medical Devices Regulations (SOR/98-282)  European Medical Device Directive EU MDD 93/42/EEC      
 
Critical Skills:  
Fluency in English – verbal, written and presentation skills.     
Proficiency with all Microsoft Office applications, project management tools, and electronic document control tools.     
Strong technical, organizational, and interpersonal skills.     
Ability to prioritize, multi-task and perform in a deadline-oriented environment.     
Excellent problem solving/decision making skills.     
Strong project management and time management skills.      
Ability to work closely with multiple internal, external and cross functional teams.      
Ability to work in a fast-paced environment and have a strong sense of ownership.     
Proactive, collaborative, self-motivated, team player.