Regulatory Affairs Specialist I

04 Aug, 2022

Jobs

Regulatory Affairs Specialist I

Nova Biomedical
Waltham, MA

<p “margin-left:=”” 4.1pt;=”” margin-right:=”” 10.1pt”=””>Nova Biomedical is hiring a Regulatory Affairs Specialist to provide pre-market and post-market regulatory support to US FDA, Health Canada, EU, and other International Regulatory Licensing and Registration Requirements.

More specific responsibilities will include:

 

  • Lead and Support US 510k Submissions
  • Lead and Support Health Canada Device License Applications
  • Lead and Support Self Certified and Notified Body Reviewed EU Technical File Preparation
  • Lead Regulatory Affairs departmental projects
  • Coordinate Departmental activities for International Device Licensing and Registrations
  • Support Product Development Teams for New Product Submission Requirements
  • Leads, participate in, and Support Internal and External Quality System Audits
  • Technical Writing

 

 

Qualifications:

 

  • BS Degree in the Sciences, or equivalent MS in Regulatory Affairs is preferred.
  • 0 – 2 years IVD Regulatory experience.
  • Previous regulatory labeling review experience.
  • Experience with 510k, Health Canada, International Device Submissions, Licensing and Registration experience, ISO/FDA QSR, IVDD/IVDR, ISO 13485 knowledge.
  • Excellent technical writing skills.
  • Quality system auditing experience.
  • Certified Quality Auditor and RAC Certification is a plus.
  • Statistics and database management proficiency.

 

At Nova Biomedical, we practice our core values of mutual respect, honesty, and integrity throughout the company. With a strong sense of family in the workplace, we are proud that one third of all our employees have been with us for over 10 years.

 

Highlights of benefits offered to Nova Biomedical employees include Blue Cross Blue Shield medical plan, tuition reimbursement, matching 401K, company subsidized cafeteria and an innovative scholarship program for children of employees.

Learn more here

Job posted: 2022-08-04