Mansfield, MA Remote (Global)

Collabera is hiring a Temp to Perm - Remote Opportunity - Regulatory Affairs Manager

About the Role

About the Role

Role details below.

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
  • Be involved in EU submissions
  • Represent RA as core 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
  • Communicate with regulatory agencies on 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 int

Work Arrangement

Remote (Worldwide)

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About company
Collabera
At Collabera, we recognize that our client satisfaction depends in large part on our resource satisfaction, so we make meeting your career needs a top priority. We provide a high-touch, supportive environment that enables you to grow and challenge yourself while maintaining work-life balance. Choose from a wide range of exciting opportunities from our diverse Fortune 500 client base. Job Description: * Responsible for working with customers and designers to build custom websites. This includes HTML and CSS coding, assisting in the QA, testing and the actual publishing of the websites * Assist in providing back-up design support when needed * To be part of a team that applies knowledge of web development to build and deliver custom websites and on-line advertisements (e.g., banner ads) for customers. This includes supporting website development services as well as rich media ad design / development. Qualifications: • Associates degree or related experience in a technical field required• Professional experience in web development, including website development, building site pages and developing code• Working knowledge of developing and integrating themes into WordPress• HTML page creation from raw format design files – such as Photoshop PSD files• Fluent in CSS tableless layouts and experience with CSS frameworks such as Foundation or Bootstrap• Ability to write, debug and test scripting languages like Javascript and experience with frameworks such as jQuery and jQueryUI• API Integration into existing CMS systems (preferably WordPress)• Managing and organizing source code revisions and files with versioning tools such as Git or SVN• Build site pages, unit test, and support the implementation of customer web sites• Analyze and document user requirements.• Maintain and update new and existing customer websites• Acquire and maintain knowledge of current standards, policies and procedures• Collaborate with other team members and cross-functional units to ensure quality• Maintain and develop technical skills to keep current in systems programming and analysis techniques Additional Information: All your information will be kept confidential according to EEO guidelines.
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Job Details
Category other
Posted 3 hours ago