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Regulatory Affairs Specialist

Company: Katalyst Healthcares & Life Sciences
Location: Clifton
Posted on: May 28, 2023

Job Description:

Responsibilities :

  • Acts as a core team member on sustaining and new product development projects, providing regulatory feedback and guidance throughout the product development cycle.
  • Develops and executes regulatory strategies for new and modified products.
  • Works with regulatory and cross-functional peers to resolve potential regulatory/technical issues and questions from the regulatory agencies.
  • Manages the release and shipment of products under regulatory controls to all regions.
  • Provides recommendations for how to overcome regulatory barriers and resolve any disputes within teams as to the importance of regulatory requirements.
  • Coordinates and prepares regulatory submissions for new and modified products ensuring compliance with applicable regulatory requirements and company policies.
  • Handles the preparation and processing of documentation required for new product introductions and revised products in international markets.
  • Reviews and approves design and manufacturing changes for existing products, ensuring compliance with applicable regulations.
  • Provides technical guidance and regulatory training to cross-functional teams.
  • Reviews device labeling and advertising materials for compliance with applicable regulations and recommends appropriate changes.
  • Monitor the development of new regulatory requirements and advise of the impact to cross-functional teams.
  • Develops and maintains procedures to ensure compliance and support business goals.
  • Maintains proficiency in government regulations and guidance's.
  • Support other regulatory requests or projects as needed.

    Requirements :

    • Bachelor's degree with a minimum of 2 years of medical device industry experience
    • Prior experience with regulatory submissions, such as PMA or 510(k)
    • Working knowledge of FDA and international regulations for medical devices
    • General understanding of the product development process and design controls
    • Ability to manage several projects simultaneously.
    • Strong interpersonal and influencing skills.
    • Ability to independently manage projects, prioritize time and communicate effectively.

Keywords: Katalyst Healthcares & Life Sciences, Clifton , Regulatory Affairs Specialist, Other , Clifton, New Jersey

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