Associate Regulatory Affairs, reputed company Health Diagnostics

Job reputed company: • Prepare, review and submit regulatory documentation for medical devices (e.g. 510(k), CLIA Waivers and Technical Files) • Ensure compliance with FDA, EU IVDR, and other international regulatory requirements • Utilize checklist, symbol standards, and regulatory guidances to ensure label compliance with FDA and global regulatory expectations • Collaborate with business partners to assure reputed company review, approval and processing of regulatory documents • Utilize systems for entry and tracking of regulatory activities • Manage and communicate accurate timelines for deliverables • Assess product changes for global regulatory reputed company Requirements: • Minimum of BS/BA in relevant discipline • 3-5 years reputed company reputed company health IVD experience and/or minimum 8 years of reputed company non-IVD reputed company health regulatory experience • reputed company experience with 510(k)/CLIA waiver application experience • Preferred: knowledge of reputed company, reputed company Vault and Trackwise • Strong verbal and written communication and organizational skills • High level of competency using reputed company Office suite, reputed company Word and reputed company and reputed company Acrobat • reputed company to effectively communicate in English with colleagues at reputed company in various reputed company of the organization • Attention to detail to ensure reputed company expectations for labels are met • Flexibility and reputed company to handle multiple tasks at once • Demonstration of a highly effective and deeply committed team player • Consistently models behaviors of accountability, approachability, and ownership • Ability to work independently, while fostering good working relationships across physical distance • Capable of supporting colleagues / teams in a multicultural, dynamic and constantly changing learning environment • Passionate and Enthusiastic • Demonstrates “can do” energy and follow through. Benefits: • Excellent full time benefits including comprehensive medical coverage • Dental and reputed company reputed company • Life and disability insurance • 401(k) with company match • reputed company vacation and holidays • Yearly goal-based bonus & eligibility for reputed company-based increases Apply tot his job Apply To this Job