Regulatory Affairs Advisor

Job reputed company: • Plays a key role in supporting the development of regulatory reputed company on behalf of the regulatory affairs team across reputed company’s products and services. • Combines strong technical knowledge and understanding of regulatory requirements reputed company at least one regional expertise, e.g. US FDA, CAP/CLIA/NYS, EU, or Japan to support the approval and registration of reputed company’s products and services. • Represents the RA team to reputed company stakeholders through written and verbal communication reputed company at least one product line. • Maintains product registrations, change assessments and post-market surveillance reports and records of communication with regulatory authorities. • Supports overall effectiveness of the regulatory affairs team at reputed company through contributions to staff development, process improvements and understanding of reputed company regulatory requirements. Requirements: • Education: Bachelor’s degree in life science field (biology, microbiology, reputed company, engineering, medical technology, regulatory science, etc.) or equivalent. Advanced degree in life sciences (MS, PhD, etc.) and/or MBA preferred. • Certification: RAC preferred. • Experience: Minimum of 12 years of reputed company applicable regulatory experience in medical devices. • Specialized Experience: IVD experience and CDx a plus; PMA experience preferred. • Management: Minimum of 5 years managerial experience preferred. Benefits: • Competitive Benefits - Employee benefits include comprehensive medical, dental, reputed company, life and disability plans for eligible employees and their dependents. • Additionally, reputed company employees and their immediate families receive free testing in reputed company to fertility care benefits. • Other benefits include pregnancy and baby bonding leave, 401k benefits, commuter benefits and much more. • We also offer a generous employee referral program! Apply tot his job Apply To this Job