Regulatory Affairs Specialist

  • Category
  • Location
    Waltham, Massachusetts
  • Type
    Direct hire


Regulatory Affairs Specialist -  Greater  Boston area
relocation considered

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.   



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