Senior Manager Regulatory Affairs in London - Qiagen

Job Overview

London, England
Job Type
Full Time
Date Posted
4 days ago

Additional Details

Job ID
Job Views

Job Description

OverviewAt 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 DescriptionWe are looking for candidates based around Europe.The position requires the ideal candidate to participate on project development teams. Potentially manage a small team of employees that oversee the product change control process from a regulatory perspective.Participate on project development teams and represent regulatory affairs by supporting project and product teams.Prepare regulatory submissions as required for global approvals for in vitro diagnostic (IVD) products, including preparation of reports and interaction with regulatory officials as required.Prepare and submit to notified body Technical Documentation needed to demonstrate compliance with applicable European Regulations (IVDR, MDR).Prepare regulatory submissions for US (e.g. 510k, PMA) and Health Canada (e.g. Class III) approvals for QIAGEN IVD products,Research and interpret regulations, guidelines and precedents to support interdepartmental project teams in developing strategies, policies and procedures that ensure regulatory compliance with global regulatory agencies.Interface with regulatory agencies for inquiries and issuesSupport product change control process from a regulatory perspective and lifecycle management of product US annual reports and Health Canada Summary reportsPosition RequirementsThe ideal candidate will have 5 years of experience in a regulated industry, with at least 3 years experience in Regulatory Affairs preparing EU Technical Documentation, US FDA 510(k) and/or PMA submissions, preferably IVD experience.Possess a working knowledge of the MDR and IVDR, applicable ISO standards, and US medical device (IVD) regulation.Demonstrated organizational, planning, and prioritizing abilities, as well as strong technical writing ability.Demonstrated strong attention to detail; ability to work under pressure to meet deadlines.Ability to work on complex problems and exercise sound science-based decision making in developing regulatory strategies and solutions to regulatory problems.Flexibility to adjust to changes in schedule, priorities, product availability and perform multiple tasks simultaneously.Personal RequirementsGood verbal and written communications skills and the ability to convey complex regulatory requirements in a straightforward and practical manner.Working knowledge of MS-Word, Excel.Command of the spoken and written English language is required.Must be articulate and able to communicate effectively with employees at all levels of the organization on the telephone and in person as well as with key individuals outside the organization, e.g. FDA reviewers, consultants.What we offerAt 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, sex, age, national origin, religion, sexual orientation, gender identity, status as a veteran, or disability.


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