Principal Regulatory Affairs Specialist

3 months ago

atlanta, United States Accordance Search Group Full time

Our client is looking for a Principal Regulatory Affairs Specialist to work on-site in Atlanta, GA.


As an individual contributor, the Principal Regulatory Affairs Specialist is responsible for providing regulatory guidance to cross-functional partners, developing global regulatory strategies for new and modified Class III devices and preparing and submitting regulatory submissions in the US, EU and outside of US (OUS) geographies.


Responsibilities

  • Acts as a regulatory representative on core product development teams, communicates regulatory requirements and impact of regulations to project teams, and provides input related to FDA and international product registrations and licensing requirements.
  • Develops global regulatory strategies for new and modified products.
  • Prepares and submits PMA and IDE Submissions and Supplements. Works with international affiliates to compile and submit international product registrations and licensing applications.
  • Interprets new or existing regulatory requirements as they relate to the product portfolio and regulatory and quality system procedures.
  • Reviews and advises on labeling, product claims, marketing brochures, and other publications to ensure compliance with regulations.
  • Maintains annual licenses, registrations, and listing information. Assists with compliance to product post-marketing approval requirements.
  • Supports the product release process by creating GTS licenses or reviewing and approving requests for product release.
  • Supports all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
  • Complies with U.S. Food and Drug Administration (FDA) and international regulations, other regulatory requirements, Company policies, and governing procedures and processes.
  • Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
  • Reviews protocols and reports to support regulatory submissions.
  • Creates, reviews and approves engineering change requests.
  • Acts as liaison between the Company and the various regulatory agencies. Interfaces directly with FDA and Notified Bodies.


Required Qualifications

  • Bachelor’s Degree in Scientific discipline e.g. Chemistry, life Sciences, Biology (or equivalent vocational qualifications)
  • Experienced in regulatory submissions for in vitro diagnostic devices and/or medical devices.
  • Experience of working within the requirements of 21 CFR 820, ISO 13485, the Medical Devices Directive (93/42/EEC) and/or the IVD Directive (98/79/EC).

Preferred Qualifications

  • 5-7 years’ experience in a regulated industry with a minimum of 3 of those years directly related to Class III Medical Devices.
  • Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society).
  • Ability to work effectively on project teams.
  • Must be able to manage multiple and competing priorities and manage programs with minimal oversight.
  • Strong written, verbal, presentation, and organizational skills.
  • Strong analytical and problem-solving skills.
  • Working knowledge of QSR, ISO, and EN standards. Strong working knowledge of regulatory requirements for US, EU (EU MDR), and other international geographies.
  • Experience with medical device software requirements and software regulations.
  • Ability to identify risk areas and escalate issues as appropriate.

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