Nova Biomedical
Regulatory Affairs Specialist II/Sr.
Nova Biomedical, Waltham, Massachusetts, United States, 02254
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.Responsibilities:Lead and support of US 510k SubmissionsLead and support of Health Canada Device License ApplicationsLead and support of International Device Licensing and RegistrationsSupport product development teams for new product submission requirementsProduct Technical Files development and maintenanceReview and approval of ECOs related to assigned projectsParticipate in Quality System AuditsTechnical writingSupport UDI labeling projectQualifications:BS Degree in Sciences, or equivalent MS in Regulatory Affairs is preferred2+ years (Level II) or 3+ years (Sr. Level) IVD experiencePrevious experience with 510k, Health Canada, International Device Submissions Licensing and Registration experienceISO/FDA QSR, IVDD/IVDR, ISO 13485 knowledgeExcellent technical writing skillsQuality system auditing experience is preferredStatistics and database 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.
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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.Responsibilities:Lead and support of US 510k SubmissionsLead and support of Health Canada Device License ApplicationsLead and support of International Device Licensing and RegistrationsSupport product development teams for new product submission requirementsProduct Technical Files development and maintenanceReview and approval of ECOs related to assigned projectsParticipate in Quality System AuditsTechnical writingSupport UDI labeling projectQualifications:BS Degree in Sciences, or equivalent MS in Regulatory Affairs is preferred2+ years (Level II) or 3+ years (Sr. Level) IVD experiencePrevious experience with 510k, Health Canada, International Device Submissions Licensing and Registration experienceISO/FDA QSR, IVDD/IVDR, ISO 13485 knowledgeExcellent technical writing skillsQuality system auditing experience is preferredStatistics and database 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.
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