RAQA Specialist - Virtual

Our client, a Global Leader in the Medical Device Industry has an immediate opening for a RAQA Specialist for a 12 month + Contract.  Our client offers results-driven people a place where they can make a difference - every day!  You will also have the opportunity to work with other like-minded, self-directed and detail oriented Top Talents in an extremely collaborative and professional environment. 

Position Description (Principle Duties and Responsibilities)

The daily work of this role involves lots of technical documentation review. Experience with QMS systems such as Agile is nice to have, but not 'must have'  since our client will provide training.  The person will review product files, compare to regulations/standards, participate in stakeholder meetings, monitor project plans and schedule, compile files, and provide administrative support to ensure project deadlines are met in a timely manner.   

• Review reports of customer complaints and assess them for regulatory reporting. 
• Submit initial and follow-up reports to device related agencies as appropriate. 
• Process Additional Information (AI) request letters from regulatory agencies. 
• Analyze complaint data. 
• Work with customers and sales forces to resolve complaint issues. 
• Interact with device related Agencies on vigilance reports and incidents. 
• Recommend corrective and/or preventive actions to address non-conformities and deviations. 
• Work and train other departments on their complaint handling responsibilities. 
• Assist in developing solutions and processes to manage complaints. 
• Maintain current on TrackWise system. 
• May review and approve non-conformances and planned deviations. 
• May aid in developing and executing process and product protocols and reports. 
• May provide backup phone support to the complaint hotline. 
• May work with pre-market Regulatory personnel in developing post-market product requirements. 
• Support management of high-level projects and initiatives, with responsibilities that include defining, managing and executing project charters and partnering with cross-functional groups to establish roles, responsibilities, and deliverables. 
• Capable of clearly identifying, analyzing, and understanding potential risks and problems and work with management to and assure the appropriate actions are taken. 
• Author and update divisional SOPs, recommend timely changes to ensure regulatory compliance, and support process improvement initiatives to maximize efficiencies.

Requirements

• Bachelor's degree required in Engineering or Science
• Experience working in medical device, biologics and/or pharmaceutical field preferred 
• Proficient in Microsoft Office, Excel and Powerpoint 
• Knowledge of applicable international regulations and standards (CFR, EU MDR, QSR, ISO 13485, MDSAP, etc.) 
• Ability to interface with both technical and non-technical personnel at all organizational levels 
• Technical writing experience preferred 
• Ability and versatility to manage changing priorities and workflow for multiple projects and deadlines 
• Regulatory Affairs Certification and or ASQ Certification preferred 
• Prior experience working in a virtual/remote environment with demonstrated capabilities to work with minimal supervision.