Regulatory Associate

Werfen is a growing family-owned innovative company founded in 1966 in Barcelona Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis Acute Care Diagnostics Transfusion Autoimmunity and Transplant. Through our Original Equipment Manufacturing (OEM) business line we research develop and manufacture customized assays and biomaterials. We operate directly in 30 countries and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe and our workforce is more than 7000 strong.

Our success comes from a specific focus in these rapidly evolving diagnostic areas our commitment to customers and our dedication to innovation and quality. Were passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care.

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.

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.

Minimum Knowledge & Experience required for the position:

Education:

• Bachelors 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

If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV.

Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination harassment or retaliation based upon an individuals 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 for assistance.

We operate directly in over 30 countries and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7000 employees around the world comprise our Werfen team.