Principal Regulatory Affairs Specialist

Position Overview:  
The Principal Regulatory Affairs Specialist will lead strategic regulatory initiatives and projects as subject matter expert which support both domestic and international market authorization and compliance including working with Marketing, New Product Development, Manufacturing and Engineering.  
 
Responsibilities:  
• Lead strategic regulatory initiatives and projects to ensure regulatory approval and compliance of medical devices in both domestic and international markets. Provide regulatory affairs expertise for aspects of product development, product manufacturing, and/or clinical studies including pre-market, post-market and physician initiated studies. Provide Regulatory support to on-going compliance and corporate initiatives. 
• Compile and submit documentation as required in support of marketing initiatives.  
• Represent Regulatory Affairs on strategy and compliance project teams in areas of expertise. 
• Lead or support the expert review of pre-market filings as appropriate (Q-Sub, 510(k), IDE, PMA, PMA updates, CE Marking, Canadian Registrations, EU Registrations, and ROW registrations). 
• Lead in planning, creating, organizing and interpreting regulatory documents for strategic regulatory initiatives. 
• Review and approve project documentation such as specifications, procedures, schedules, test protocols and reports, validations, etc, as required depending on project. 
• Performs other duties as required. 
 
Education and Experience: 
• B.S. / B.A. or equivalent combination of education and experience. 
Minimum Requirements: 
• 8+ years of regulatory medical device industry experience. 
• RAC Certification preferred. 
• Knowledge of regulatory guidelines and requirements (domestic and international).  
 
Preferred Skills and Competencies:  
• Effective verbal and written communication skills 
• Experience with reviewing Clinical Evaluation Plan/Reports. 

• Experience with mobile medical device applications, wearables, and cloud enabled systems. 
• Understanding of 21 CFR 820, CMDR, ISO 13485, EU MDR, IEC 62304, IEC 62366-1. 
• Team player ready to work hard on a dedicated team  
• Ability to communicate at multiple levels of an organization. 
• PC skill, word processing, spreadsheet, database, specifically: Word, Excel, PowerPoint, Visio, Project. 
• Ability to organize and manage multiple priorities. 
• Ability to generate and maintain accurate records. 

Additional Information:

The US base salary range for this full-time position is $109,125.00 - $163,687.50. Our salary ranges are determined by role, level, and location. The range displayed on each job posting reflects the minimum and maximum target for new hire salaries