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Regulatory Affairs Specialist II in Marlborough, MA at Angiodynamics, Inc.

Date Posted: 5/9/2018

Job Snapshot

Job Description

Responsible for determining the path to market for new and modifications to existing products in compliance with Regulations of intended market territory and for guiding teams on the required deliverables to support the Regulatory status of products distributed by Angiodynamics, Inc.
  • Under minimal supervision, acts as company representative, developing and maintaining positive relationships with device reviewers through oral and written communications regarding pre-submission strategy/regulatory pathway development, testing requirements, clarification and follow up of submissions under review.
  • Assist with developing and implementing regulatory strategies for new and modified medical devices.
  • Research and prepare recommendations on pathway for a new device, proposed device change or modification (e.g. 510(k), PMA, Design Dossier, Shonin, Canadian License).
  • Apply scientific/technical knowledge to guide and strengthen development of regulatory submissions.
  • Compile necessary information and prepare Regulatory license applications that meet specific country requirements to support international markets, as well as internal regulatory file documentation
  • Prepare and maintain Technical Documentation Files (EU Tech Files and Design Dossiers; and IC Dossiers)
  • Review device labeling and advertising materials for compliance with regulatory product approvals (submissions/licenses) and applicable country regulations; analyze and recommend appropriate changes.
  • Review and recommend action on product and manufacturing changes in compliance with applicable regulations.
  • May act as a core team member on development teams, providing Regulatory Affairs feedback and guidance throughout the product development cycle.
  • Develop and maintain products listing/establishment details required to prepare documentation for product importation into USA and into International sites.
  • Prepare Export Certificates (CFGs, CFS, etc.)– apply knowledge of specific country requirements to obtain approvals from USA regulatory agencies and International embassies
  • Prepare product and establishment registration/listing with Regulators (e.g., USA (FDA, Customs), Europe (AR, NB, CA), Australia, Health Canada).
  • Collaborate with internal (Quality/Ops/R&D) and external (Partners/Distributors) groups to obtain documentation necessary to develop required Field Action reports to Regulators (e.g., FDA, CA, EU) including Initial, Interim and Close-out Report
  • Liaison with global Regulatory partners.
  • Contribute as a team member on projects sustaining the regulatory and quality compliance of products and the continued enhancement of the organization
  • Support and maintain Quality initiatives in accordance with the Quality Policy.