Temp to Perm - Remote Opportunity - Regulatory Affairs Manager

Job description

Required: (Remote Opportunity - Temp to Perm) • The Regulatory Affairs Manager ensures compliance to FDA and other applicable regulations. • In this role, you will lead the preparation, analysis, and submissions dossiers to various governing agencies in supporting business growth. • The RA Manager supports compliance with applicable regulations including ISO, local, state, and/or federal requirements. • Preparing international regulatory submissions and FDA submissions which may include device 510(k), IDEs, PMAs) and serving as regulatory representative on selected project teams; developing departmental SOPs/policies regarding regulatory matters. Key responsibilities: • Lead Regulatory Associates or Specialists in addition to work as an individual contributor • Prepare, review and file FDA premarket submission to ensure devices are commercially available in the U.S.: pre-IDEs, IDEs, 510(k)s, PMAs and PMA Supplements. (Will also be involved in EU submissions) • Represent RA as core team member to drive innovation on Tech. Dev. Projects and follow through to market release. • Develop Regulatory Strategies for new or modified products and prepare project plans & budgets. • Monitor and provide management with impact of changes in the Regulatory environment. • Communicate with regulatory agencies on administrative and routine matters in addition to pre-clinical, pre-submission, and submission discussions under the direction of management. • Document, consolidate and maintain oral and written communication with FDA, notified bodies, and clinical investigators. • Support Design Control process. • Prepare Rational to file documentation for modifications to devices when appropriate. • Participate in FDA & other notified body Inspections. • Author and/or review regulatory procedures and update as necessary. • Review change control documents and ascertain Regulatory impact for external and internal documents. • Assist in development/maintenance of regulatory files, records and reporting systems of systematic retrieval of information. • Review promotional material and labeling for regulatory compliance. Required qualifications:(Remote Opportunity) • Bachelor's degree required. Scientific or engineering field preferred. • 5+ years of medical device regulatory affairs experience. • Must have authored 510(k) submissions • Must have knowledge of U.S. FDA regulations and standards • 3+ years of experience interacting with FDA and/or other regulatory agencies • Experience with devices containing software is strongly preferred. • Must work well in team environments • Must demonstrate leadership skills in team setting. • Proven analytical abilities • Solid understanding of manufacturing and change control, and an awareness of regulatory trends To know more on this position or to schedule an interview, please contact; Ujjwal Mane 973-805-7557 ujjwal.mane[@] Established in 1991, Collabera has been a leader in IT staffing for over 22 years and is one of the largest diversity IT staffing firms in the industry. As a half a billion dollar IT company, with more than 9,000 professionals across 30+ offices, Collabera offers comprehensive, cost-effective IT staffing & IT Services. We provide services to Fortune 500 and mid-size companies to meet their talent needs with high quality IT resources through Staff Augmentation, Global Talent Management, Value Added Services through CLASS (Competency Leveraged Advanced Staffing & Solutions) Permanent Placement Services and Vendor Management Programs. Collabera recognizes true potential of human capital and provides people the right opportunities for growth and professional excellence.