Regulatory Associate

Werfen is a global diagnostics leader founded in 1966 in Barcelona, Spain. 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, the position will prepare and submit supplements and amendments to FDA for approval, including responding to deficiency letters, and 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 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. Recognizes and elevates critical regulatory/compliance issues to RA management. Assists with preparation of documentation for regulatory and third‑party inspections. Supports regulatory tracking, archival, and information management activities. Networking / Key Relationships Works closely with Regulatory Affairs members, quality assurance, manufacturing, customer service, shipping, sales and marketing staff. Qualifications Education: Bachelor’s degree in science, engineering or related field required. Experience: Minimum of 1–3 years of experience in US, EU, and international regulatory affairs within the medical device industry required. Skills & Capabilities: Knowledge of FDA medical device and/or biologics regulations and guidance, Regulation (EU) 2017/745 or 2017/746 (IVDR), 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. Ability to manage multiple tasks and deadlines. Works precisely according to procedures, rules and regulations, has 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 Equal Employment Opportunity Statement 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