Regulatory Affairs Specialist 4
  • Franklin Lakes, New Jersey, US
  • +914043515100
4 Days ago
Job Description

RESPONSIBILITIES:

  • Provides regulatory leadership to assigned product development program teams by providing regulatory guidance throughout the product development cycle and coordinating team inputs for regulatory submissions.
  • Works with business and cross-functional team to ensure alignment of global regulatory strategies with business objectives and implementation of the strategic plans.
  • Assesses regulatory pathways for new products and product modifications; develops regulatory strategies and tactical plans for submissions to international regulatory bodies.
  • Prepares and submits US 510(k) submissions.
  • Identifies and communicates potential risks and mitigations associated with reg. strategies.
  • Coordinates interactions/negotiations with U.S. regulatory agencies.
  • Participates in internal/external trade, professional, and standards development organizations.
  • Reviews and approves labels, labeling, and promotional materials.
  • Review’s product design and change documentation, performs regulatory assessments, and implements required regulatory actions.
  • Reviews clinical protocols to assure collection of appropriate data for regulatory submissions and regulatory compliance.
  • Monitors worldwide regulatory developments (standards, guidance documents) and communicates emerging opportunities/concerns impacting BU products.
  • Act as Global Business to Business RA Lead supporting pharmaceutical customer regulatory activities (ie, Combination Device Submissions, Letter of Authorization Request, Product Registration Status)
  • Carry out the above tasks without supervision.

 

Requirements:

  • Ability to read, analyze, and interpret regulatory literature and documents.
  • Proficient in using Microsoft Word, Excel, PowerPoint, and Project.
  • Strong communication (written, oral) and project management skills.
  • Able to handle multiple competing tasks with attention to detail.
  • Strong critical thinking skills.
  • Able to work independently to achieve objectives on or before schedule.
  • Demonstrated global perspective, customer-centered, cross-functional collaboration, and partnership skills.
  • Extensive knowledge of US medical device regulations, 21 CFR 820 -Quality System Regulation, and standards, FDA guidance documents, Good Clinical Practice standards, Good Laboratory Practice regulations.
Industry
  • NA

Required Skills
  • Regulatory Affairs Specialist 4

Experience
  • 2-4 Years of Experience

Salary
  • NA

Working Hours / Week
  • 40h