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Regulatory Affairs Associate I # 26-24079

US Tech Solutions

Role overview

Qualifications

  • Knowledge of regulations
  • Scientific knowledge
  • Administrative and project management skills
  • Technical system skills (e.g. word processing, spreadsheets, databases, online research)

Responsibilities

  • Supports regulatory project plan execution
  • Maintain awareness of regulatory requirements and ensure continued learning
  • Compile and prepare responses to questions from regulatory authorities according to plan
  • Track status and progress of regulatory documentation

Key facts

  • Remote from: New York (USA)
  • Full time
  • Regulatory Affairs Associate
  • English

Hard skills

Other skills

  • Technical Acumen
  • Editing

About the company

US Tech Solutions logo

US Tech Solutions

Staffing & Recruiting

USTECH SOLUTIONS is the largest privately owned diversity workforce partner with a global footprint. For 20+ years, we have partnered with leading MSPs and some of the world’s largest enterprises to deliver a flexible workforce. We serve Fortune 500 giants and growing businesses alike, reinventing the role of humans in a digital workforce. ‘Reinventing Human’ is about connecting you with top talent and seamlessly integrating new hires into your programs through our next gen AI powered Talent platforms. As the largest private diversity supplier in the US, we champion inclusion and unlock hidden potential. We work with leading MSPs and are a trusted strategic partner to the world’s top brands. At USTECH SOLUTIONS, we're inverting the talent hiring pyramid by offering a range of solutions from curated talent pools, workforce management services, and IT services resourcing to IC compliance. Our legacy and close affinity to the computing industry has equipped us with the expertise and vision to provision AI platform solutions that help organizations to innovate faster. Considering Statement of Work? Meet US Tech Digital (ustechdigital.com). We're helping businesses achieve digital leadership through our tailored SOW solutions, utilizing market-leading technology products and our proprietary in-house developed platform solutions. Explore our full range of services and solutions by visiting our website: ustechsolutions.com

Company details

Company typeLarge
IndustryStaffing & Recruiting
Company size1001 - 5000

Links

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Job description

Duration:12 Months Contract

US Remote
Under W2 hourly, contract
  • Responsible for the global coordination and the preparation of documents/packages for regulatory submissions. In this position you will also review and evaluate technical and scientific data and reports required for submission in support of global *** products.

Top three to five technical skill requirements-
  • Familiar with USA and OUS device regulations (specifically EU device regulations)
  • Experience with RA strategy development
  • Experience with working with Cross functional team members
  • Experience with interaction with external Regulators (FDA, TUV)
  • Experience with working with medical devices

Essential Duties and Responsibilities
  • Supports regulatory project plan execution
  • Maintain awareness of regulatory requirements and ensure continued learning
  • Maintain regulatory files in a format consistent with requirements
  • Participate as an active team member of project teams as required
  • Compile and prepare responses to questions from regulatory authorities according to plan
  • Edit and proofread regulatory documentation
  • Assist in preparation and review of labeling, SOP’s, and other departmental documents
  • Compile under supervision regulatory documents for submission
  • Track status and progress of regulatory documentation
  • Understand Regulatory Affairs' position in small project teams

Qualifications
  • Knowledge of regulations
  • Scientific knowledge
  • Administrative and project management skills
  • Ability to contribute to multiple projects from a regulatory affairs perspective
  • Technical system skills (e.g. word processing, spreadsheets, databases, online research)
  • Proofreading and editing skills

Education and/or Experience
  • Bachelor’s degree or country equivalent in a relevant scientific discipline
  • Suitable candidates with a non-scientific degree may be accepted and undertake further training e.g. under an apprenticeship or similar post graduate qualification
  • Regulatory experience preferably within a healthcare environment

About US Tech Solutions:
US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com.

US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

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