Regulatory Affairs Specialist
Regulatory Affairs Specialist - Greater Boston area
Mid-level career opportunity - IVD or IVDR experience is required.
Our Client, located in the Greater Boston area, is hiring a Senior Regulatory Affairs Specialist. This role will focus on assuring company compliance to US 510K, Health Canada Licensing, International Device Submissions, Licensing requirements, ISO/FDA QSR, IVD and IVDR, ISO 13845 and quality system auditing.
* Lead and support of US 510K Submissions
* Lead and support of Health Canada Device License Applications
* Lead and support of International Device Licensing and Registrations
* Support product development teams for new product submission requirements
* Product Technical Files development and maintenance
* Review and approval of ECO’s related to assigned projects
* Participate in Quality System Audits
* Technical Writing
* Support UDI labeling project
* 5+ years IVD or IVDR or medical device experience
* BS Degree in Sciences or equivalent
* MS in Regulatory Affairs is preferred
* Excellent technical writing skills
* Quality system auditing experience is preferred
* Statistics and database management proficiency preferred
* Certified Quality Auditor and RAC Certification are a plus
Our Client is doing great things in advancing novel medical devices to the market. This is a great opportunity to advance your career with a company who has a strong global presence, is financially stable and is investing in new technologies and it's employees. The company offers a competitive salary structure and generous benefit package.