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Regulatory Affairs Specialist II/Sr.

2 months ago

Watertown, United States Nova Biomedical Full time

Nova Biomedical is hiring a Regulatory Affairs Specialist (Level II or Senior Level) in our Waltham, MA facility (Hybrid) to focus on assuring company compliance to US 510k, Health Canada Licensing, International Device Submissions, Licensing and Registration requirements, ISO/FDA QSR, IVDD, ISO 13485, quality system auditing.

More specific responsibilities will include:

  • 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 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 or medical device 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.

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.