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.
Position Description
Lead the regulatory review of all labeling based on the various domestic and international requirements - including product labels, instructions for use, e-labeling, website, advertising, and promotional materials.
Provide support to currently marketed products, e.g., review engineering changes, labeling, promotional material, product changes and documentation for compliance for changes requiring regulatory agency approval, as pertains to U.S. and international regulatory requirements.
Interpret, understand, and apply U.S. and international in vitro diagnostic (IVD) device regulatory requirements, statutes, regulations, policies and guidance documents to various projects.
Manage the revision history of all product labeling and coordinate the translation of approved product labeling into the required languages of international markets while upholding all applicable requirements.
Maintain product technical files for ongoing activities related to compliance with global directives and regulations.
Create and manage control of UDI requirements and listings.
Assist with the submission activities for a variety of in vitro diagnostic device regulatory approvals including CE mark, U.S. premarket approvals (PMAs), U.S. premarket notifications (510(k)s), post-approval reports, export certificates, establishment registrations and listings, etc.
Contribute to the planning and design of internal studies (including feasibility studies), premarket clinical studies and post-market surveillance activities in support of U.S. FDA and international regulatory submissions, as required.
Lead the effort for creation of operating procedures and policy guidelines regarding US and CE-IVD labeling requirements.
Perform other duties as required or assigned.
Position Requirements
Bachelor's degree required in a science, engineering or related technical field; advanced degree preferred.
Minimum 5 years of experience in regulatory labeling; IVD experience highly desired.
Experience in medical device labeling, including Instructions For Use (IFUs), preferably IVD.
Experience with CE Mark Technical File and Design Dossier submissions for Medical Devices, preferably for In Vitro Diagnostic Systems.
Regulatory Affairs Certificate (RAC) preferred.
Experience working effectively in a cross-functional team setting.
Ability to comprehend principles of engineering, physiology and medical device use.
Personal Requirements
Strong organizational skills, effective writing skills and meticulous attention to detail.
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 groups.
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.
