Regulatory Affairs Specialist

12 hours ago


Watertown, Massachusetts, United States Nova Biomedical Full time
Regulatory Affairs Specialist

Nova Biomedical is seeking a highly skilled Regulatory Affairs Specialist to join our team in Waltham, MA. As a key member of our regulatory team, you will be responsible for ensuring company compliance with US 510k, Health Canada Licensing, International Device Submissions, Licensing and Registration requirements, ISO/FDA QSR, IVDD, ISO 13485, and quality system auditing.

Key Responsibilities:
  • Lead and support US 510k Submissions
  • Lead and support Health Canada Device License Applications
  • Lead and support International Device Licensing and Registrations
  • Support product development teams for new product submission requirements
  • Product Technical Files development and maintenance
  • Review and approval of ECOs related to assigned projects
  • Participate in Quality System Audits
  • Technical writing
  • Support UDI labeling project
Qualifications:
  • BS Degree in Sciences, or equivalent MS in Regulatory Affairs is preferred
  • 2+ years (Level II) or 3+ years (Sr. Level) IVD experience
  • Previous 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 is preferred
  • Statistics and data base management proficiency preferred Certified Quality Auditor and RAC Certification are pluses

Nova Biomedical values mutual respect, honesty, and integrity. We offer a strong sense of family in the workplace, with one third of our employees having been with us for over 10 years. Our benefits include Blue Cross Blue Shield medical plan, tuition reimbursement, matching 401K, company subsidized cafeteria, and an innovative scholarship program for children of employees.



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