Regulatory Associate

Werfen • Norcross, GA

2d

About The Position

The Regulatory Associate is responsible for ongoing support of regulatory activities, including preparation and submission of annual reports, PMS reports, foreign registrations, labeling change requests and tracking of field action alert documentation. Additionally, this position will support the preparation and submission of supplements and amendments to FDA for approval, which includes responding to deficiency letters. This role will also support other team members, as needed. Performs tasks that support quality system compliance with US FDA Quality System Management Regulation (21 CFR 820) and biologic regulations (21 CFR 600-680), Canadian Medical Devices Regulations (SOR/98.282), In- Vitro Diagnostic Regulation (IVDR) (EU) 2017/746, ISO 13485:2016 and other applicable international medical device regulations.

Requirements

• Bachelor’s degree in science, engineering or related field required.
• Minimum of 1-3 years of experience in the US, EU, and international regulatory affairs within the medical device industry required.
• Knowledge of and experience with FDA medical device and/or biologics regulations and guid-ance, Regulation (EU) 2017/745 or 2017/746 (IVDR) and guidance, Good Clinical Practices guidance, ISO 13485:2016 Quality System standards, ISO 14971:2019 Risk Management, and other applicable US and international regulations, guidances, and standards, preferable.
• Ability to manage multiple task and deadlines.
• Works precisely according to procedures, rules and regulations, has a passion for continuous improvement and quality.
• Demonstrates the highest ethical standards, actively promotes trust, respect and integrity in all dealings both inside and outside the Company.

Responsibilities

• Routes labeling change requests for revisions to current products.
• Proofreads labeling drafts as requested.
• Prepares and submits Annual Reports, PMS reports, Medical Device Reports (MDRs), amendments, and other correspondences, as needed.
• Supports the collection of documents for foreign registrations.
• Provides general support to regulatory team members
• Recognize and elevate critical regulatory/compliance issues to RA management.
• Assist with preparation of documentation for regulatory and third-party inspections.
• Support regulatory tracking, archival, and information management activities.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 1,001-5,000 employees