Director of QA/RA Location: Danvers, MA            Salary: Commensurate with experience >> Click here to apply online << Position Requirements Include: Bachelors degree and preferably MBA 7-10+ years of experience in Class II Medical Device QA/RA and clinical affairs. 7+ years of experience in and FDA Regulatory (ISO, MDD, QSR, CAPA…) ISO 13485 Hands-on experience with 510k Medical Device application [...]

Regulatory Affairs Specialist Location: Danvers, MA            Salary: Commensurate with experience >> Click here to apply online << Position Requirements Include: 3-5 years of experience in Regulatory Affairs of Spinal medical device products B.Sc. in Engineering or related fields Experience in regulatory submissions, including 510(k), IDE, PMA Strong knowledge of the CFR 21 QSR, ISO 13485, [...]

Quality Assurance Engineer Location: Danvers, MA            Salary: Commensurate with experience >> Click here to apply online <<   Position Requirements Include: 3 years of experience in quality assurance of Class II medical device products B.Sc. in Engineering or related fields Experience with Orthopaedic Spinal medical device products Strong knowledge of the CFR 21 QSR, ISO [...]

VP of Quality Assurance & Regulatory Affairs Location: Bay Area, CA Click here to apply Position Requirements: Bachelors degree and preferably MBA 15+ years of experience in Medical Device QA/RA and clinical affairs. 10+ years of experience in and FDA Regulatory (ISO, MDD, QSR, CAPA…) ISO 13485 and 9000 Hands-on experience with 510k Medical Device [...]

Quality Assurance & Regulatory Affairs Compliance Manager Location: Northeast Salary: $125,000 + 10% bonus *Urgent need* To apply, please send resumes to Apply@ArkayCareers.com Job Summary: Our client is looking for a QA/RA compliance manager to lead and manage professionals to ensure a high level of Quality Management System and regulatory compliance in the facility. This [...]