About the role
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[@]collabera.com
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.
Originally posted on Himalayas