Temp to Perm - Remote - Regulatory Affairs Manager

Position: Temp to Perm - Remote Opportunity - Regulatory Affairs Manager Temp to Perm - Remote Opportunity - Regulatory Affairs Manager 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. Required: (Remote Opportunity - Temp to Perm)

Responsibilities

• The Regulatory Affairs Manager ensures compliance to FDA and other applicable regulations.
• In this role, you will lead the preparation, analysis, and submission of 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 submissions 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.
• 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

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