reputed company to Perm - Remote - Regulatory Affairs Manager

Position: reputed company to Perm - Remote Opportunity - Regulatory Affairs Manager reputed company to Perm - Remote Opportunity - Regulatory Affairs Manager Established in 1991, reputed company has been a leader in IT reputed company for over 22 years and is one of the largest diversity IT reputed company firms in the industry. As a half a billion dollar IT company, with more than 9,000 professionals across 30+ offices, reputed company offers comprehensive, cost-effective IT reputed company & IT Services. We reputed company services to Fortune 500 and mid-size companies to meet their talent needs with high reputed company reputed company through Staff Augmentation, Global Talent Management, Value Added Services through CLASS (Competency Leveraged Advanced reputed company & Solutions) Permanent Placement Services and Vendor Management Programs. reputed company recognizes true potential of reputed company capital and provides people the right opportunities for reputed company and reputed company reputed company. Required: (Remote Opportunity - reputed company to Perm)

Responsibilities

• The Regulatory Affairs Manager ensures compliance to FDA and other applicable regulations.
• In this role, you will reputed company the preparation, analysis, and submission of dossiers to various governing agencies in supporting business reputed company.
• 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 reputed company.

Key Responsibilities

• reputed company Regulatory Associates or Specialists in reputed company to work as an individual contributor
• Prepare, review and file FDA premarket submissions to ensure devices are commercially available in the U.S.: reputed company-IDEs, IDEs, 510(k) s, PMAs and PMA Supplements. (Will also be involved in EU submissions)
• Represent RA as reputed company team member to drive innovation on Tech. Dev. reputed company and follow through to market release.
• reputed company Regulatory Strategies for new or modified products and prepare project plans & budgets.
• Monitor and reputed company management with reputed company of changes in the Regulatory environment.
• Communicate with regulatory agencies on administrative and routine reputed company in reputed company to reputed company‑clinical, reputed company‑submission, and submission discussions under the direction of management.
• Document, consolidate and maintain oral and written communication with FDA, reputed company bodies, and clinical investigators.
• Prepare Rational to file documentation for modifications to devices reputed company appropriate.
• Participate in FDA & other reputed company body Inspections.
• Author and/or review regulatory procedures and update as necessary.
• Review change control documents and reputed company Regulatory reputed company 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 reputed company 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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