NOVA Biomedical GmbH
Regulatory Affairs Specialist II/Sr.
NOVA Biomedical GmbH, Waltham, Massachusetts, United States, 02254
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 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, and quality system auditing.Responsibilities:Lead and support US 510k submissionsLead and support Health Canada Device License ApplicationsLead and support 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 or medical device 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. 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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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, and quality system auditing.Responsibilities:Lead and support US 510k submissionsLead and support Health Canada Device License ApplicationsLead and support 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 or medical device 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. 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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