Manager Regulatory Affairs at QIAGEN in Ann Arbor, Michigan

Job Description:

Overview

At the heart of QIAGEN's business is a vision to make improvements in life possible.

We are on an exciting mission to make a real difference in science and healthcare. We are still the entrepreneurial company we started out as and have today achieved a size where we can bring our full power to many initiatives and to our presence across the globe.

Our most valuable asset are our employees - more than 5000 in over 35 locations around the world. Our ambition is to ensure we have outstanding and passionate people working in the best teams and we are constantly looking for new talent to join us.

There are few players who have shaped the world of modern science and healthcare as much as QIAGEN, and we have only just started.
If you are looking to advance your career, are seeking new challenges and opportunities, enjoy working in dynamic and international, diverse teams and want to make a real impact on people's lives, then QIAGEN is where you need to be.

Join us. At QIAGEN, you make a difference every day.

NeuMoDx Molecular Inc. ("NMDx") is a Qiagen company dedicated to developing vastly superior IVD solutions for molecular diagnostic (MDx) testing in hospital and clinical reference laboratory settings. The NeuMoDx Molecular System will offer improved ease of use, lower costs and higher performance as compared to any other random access, continuous loading system for nucleic acid testing.

A Regulatory Manager / Sr. Manager position is available immediately with NeuMoDx. As a member of the Regulatory team, you will develop regulatory strategies and provide guidance to various departments for successful project completion. The individual in this role will also direct the preparation and submission of regulatory agency applications and correspondence with the FDA, EU and international registrations for NeuMoDx IVD products. Other responsibilities include reviewing submission materials and providing responses to regarding submissions to the various regulatory agencies. The individual in this position will play an important role in establishing regulatory priorities, resource allocation, and advisement to project teams in efforts to meet requirements for FDA and European Notified Bodies. The ideal candidate will have excellent communication skills, a background in working with the FDA, and interpreting regulatory guidelines including FDA, cGMP, GLP, GCP, and ICH. We are looking for a well-rounded candidate with a knack for problem solving in both team and independent settings to ensure the completion of aggressive project timelines.

Position Description

- Direct the preparation and submission of regulatory agency applications, reports, or correspondence.
- Provide responses to regulatory agencies regarding product information, issues or clarify and follow-up of submissions under review
- Review all regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, or compliance with regulatory standards
- Advise project teams on subjects such as premarket regulatory requirements
- Establish regulatory priorities or budgets and allocate resources and workloads.
- Formulate or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced
- Provide regulatory guidance and communicate regulatory information to departments or development project teams regarding design, development, evaluation, or marketing of products
- Develop regulatory strategies and implementation plans for the preparation and submission of new products.
- Develop or track quality metrics.
- Recommend changes to company procedures in response to changes in regulations or standards.
- Train staff in regulatory policies or procedures.
- May perform other duties as required or assigned.

Position Requirements

- M.S. in Biochemistry, Microbiology, Molecular Biology or related field with at least 8 years of relevant work experience, ideally in the in-vitro diagnostic industry
- Experience with regulatory submissions including 510(k) and PMA submissions.
- Regulatory Affairs Certificate (RAC) is preferable
- Experience with FDA and EU communications and submissions responses and clarifications
- Experience with CE Mark Technical File and Design Dossier submissions for Medical Devices, preferably for Invitro Diagnostic Systems
- Experience in medical device - preferably IVD - regulatory labeling, including Instructions For Use (IFUs) and product labels
- Strong organizational skills, effective writing skills and meticulous attention to detail

Personal Requirements

- Ability to work in a fast-paced/entrepreneurial team environment
- High degree of initiative with the ability to work independently with minimal supervision
- Ability to prepare and present concise information to group
- Experience working effectively in a cross-functional team setting
- Ability to comprehend principles of engineering, physiology and medical device use
- Capacity to plan and organize work while remaining flexible enough to handle multiple priorities.

What we offer

At the heart of QIAGEN are our people who drive our success. We act with passion, always challenging the status quo to drive innovation and continuous improvement. We inspire with our leadership and make an impact with our actions. We create a collaborative, safe and engaging workplace which forms the basis for high performing individuals and teams. We drive accountability and entrepreneurial decision-making and want you to excel your growth and shape the future of QIAGEN.

QIAGEN is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, and medical conditions related to pregnancy, childbirth, or breastfeeding), sex stereotyping (including but not limited to assumptions about a person's appearance or behavior, gender roles, gender expression, or gender identity), gender, gender identity, gender expression, national origin, age, mental or physical disability, ancestry, medical condition, marital status, military or veteran status, citizenship status, sexual orientation, genetic information, or any other status protected by applicable law.

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