Regulatory Associate

Overview Job Summary 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. Responsibilities Key Accountabilities 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. Networking/Key relationships Works closely with other Regulatory Affairs members, quality assurance, manufacturing, customer service, shipping, sales and marketing staff. Qualifications Minimum Knowledge & Experience required for the position: Education: Bachelor’s degree in science, engineering or related field required. Experience: Minimum of 1-3 years of experience in the US, EU, and international regulatory affairs within the medical device industry required. Skills & Capabilities: 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. Travel requirements: N/A Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact View email address on click.appcast.io for assistance. #J-18808-Ljbffr