Senior Regulatory Affairs Software Specialist
Greater Boston Area
2 days ago
We're looking for a regulatory affairs Medical Device professional with at least 5 years experience, of which at least 1 year in the Software Medical Device industry. RAC certification is preferred. As we are expanding our business and products, we are building the regulatory and clinical affairs team. In this role, you have the opportunity to contribute to growing the team and to developing your own challenging rewarding career path.
The Senior Regulatory Affairs SW Specialist (Sr. RA specialist) is responsible for the coordination and preparation of regulatory plans and document packages for regulatory submissions (FDA, Health Canada, EU, Asia, etc). The Sr. RA specialist also provides strategic input during product creation process and contributes to the department’s overall regulatory strategy plan. At PathAI, the Sr. RA Specialist cooperates closely with Product Development, Product Management, Machine Learning and Clinical Affairs.