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Regulatory Affairs Specialist II/Sr - Waltham, United States - Nova Biomedical
Description
Career Opportunities with Nova Biomedical CorporationNova Biomedical is an Equal Opportunity Employer in compliance with Affirmative Action in hiring and promoting women, minorities, veterans and individuals with disabilities.
Nova Biomedical is hiring aRegulatory 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.
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.
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