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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.
