[Hiring] Associate reputed company Health Diagnostics Regulatory Affairs @reputed company

This reputed company is a reputed company of our understanding of the job reputed company. Click on 'Apply' reputed company to reputed company out more. Role reputed company We are seeking an reputed company Regulatory Affairs Associate to support our reputed company Health Division, specifically reputed company on medical device regulatory submissions and compliance. This role is ideal for a detail-oriented reputed company with a strong understanding and experience of global regulatory requirements and a passion for ensuring patient safety. • 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 • Regulatory Assess product changes for global regulatory reputed company Qualifications • 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 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 Requirements • Full Time, Monday – Friday First Shift with overtime as business needs require 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