Director, Regulatory Affairs (Transfusion)

Job Information

Number

ICIMS-2025-9057

Job function

QA&RA

Job type

Full-time

Location

T&T - Norcross - Norcross, Georgia United States

Country

United States

Shift

1st

About the Position

Introduction

Werfen, founded in 1966, is a worldwide developer, manufacturer and distributor of specialized diagnostic instruments, related reagents, automation workcells, and data management solutions for use primarily in hospitals and independent clinical laboratories. The Company's business lines include Hemostasis, Acute Care, and Autoimmunity diagnostics, as well as Original Equipment Manufacturing. Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We're passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care.

Our North American Commercial Operations, as well as our Headquarters and Technology Center for Hemostasis and Acute Care Diagnostics, are based in Bedford, MA. Our Headquarters and Technology Center for Autoimmunity Diagnostics is based in San Diego, CA. Additionally, our Technology Center for Hemostasis and Blood Gas Reagents is in Orangeburg, NY, and our Technology Center for Whole Blood Hemostasis is in San Diego, CA.

Overview

The Director, Regulatory Affairs is responsible for leading the day-to-day activities of Regulatory Affairs with specific emphasis on global regulatory submission strategy, regulatory submissions, adverse event reporting / field actions, and interaction with global regulatory authorities related to Werfen Transfusion portfolio. The Director, Regulatory Affairs provides direct regulatory support for multiple Transfusion projects within the Transfusion Technology Center.

Responsibilities

Key Accountabilities

• Lead the overall strategy development, implementation, and coordination of regulatory affairs activities for Werfen Transfusion Technology Center. Ensure alignment of regulatory strategy to business strategy across all functional areas.
• Assess regulatory pathways and oversee the development of global regulatory strategic plans and regulatory submissions (IND / BLA / TDF / OUS Dossier) required to obtain registration for new Transfusion products under development and throughout the product's life cycle.
• Create, prepare, and submit organized and scientifically valid regulatory submissions in the US (IND, BLA, and 510(k), EU (TDF), and assist with OUS (submissions to Regulatory Authorities, and Notified Bodies).
• Manage and organize the Regulatory Affairs department ensuring that departmental objectives are implemented in line with the overall Q&R / Werfen Transfusion Corporate goals, and within Regulatory Affairs department FY budget.
• Provide guidance to Regulatory Affairs staff who participate on project teams and provide regu-latory advice and direction to ensure complete and scientifically sound product submissions.
• Provide guidance and regulatory input to various functional groups within the company to ensure optimal development of market access strategies.
• Responsible for monitoring, interpreting, and implementing current and new regulatory require-ments for US, EU, and ROW. Interact directly with regulatory authorities and represent the company in dealing with regulatory agencies on defined matters. Serves as liaison between the Company and the regulatory au-thority for specific product submissions and / or compliance activities.
• Determine an event's reportability to FDA under the Medical Device Reporting System (MDR), and to Competent Authorities for EU / EEA and Canada under Medical Device Vigilance System (MDV).
• Determine an event's reportability to FDA under the Biological Product Deviation Reporting (BPDR).
• Performs other duties and responsibilities as assigned
• Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.

Qualifications

Minimum Knowledge and Experience

Education :

Bachelor's degree in science, engineering or related field required.

Advanced degree preferred.

Experience :

Minimum of 10 years progressively responsible US, EU, and international regulatory affairs experience in a medical device industry required.

Minimum of seven (7) years of people-management experience.

BLA and / or Class III device, clinical study, and hands-on advanced quality systems experience are required.

Skills and Capabilities :

Travel requirements :

Approximate percentage of travelling time : 30%

People Manager Core Competencies :

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 NAtalentacquisition@werfen.com 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 7,000 employees around the world comprise our Werfen team.

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