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Senior Specialist Regulatory Affairs

Company: QIAGEN
Location: Germantown
Posted on: January 12, 2021

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.OverviewNeuMoDx 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 Senior Regulatory Specialist position is available immediately with NeuMoDx. As a member of the Regulatory team, you will work on regulatory submissions with the FDA and EU as well as obtain international registrations for NeuMoDx IVD products. Reviewing technical report, labeling and advertising material for compliance to existing and emerging regulations are primary responsibilities of this position. Various other responsibilities include reviewing clinical protocols to ensure data collection is adequate for regulatory submission as well as obtaining and communicating changes in domestic or international requirements and standards. The individual in this position will play an important role in developing regulatory infrastructure and documentation templates to support submissions. The ideal candidate will have an excellent background in preparing various regulatory submissions for the FDA and the EU as well as 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- Review product specification sheets, or test methods for compliance with applicable regulations and policies.- Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.- Obtain and determine internal documentation that are required in situations such as proposed device changes or labeling changes.- Prepare, compile and complete submissions to FDA and EU regulatory entities- Review advertising and marketing material for appropriateness and compliance to regulatory requirements and laws.- Review materials such as marketing literature or user manuals to ensure that regulatory agency requirements are met.- Review clinical protocols to ensure collection of data needed for regulatory submissions.- Write or update regulatory standard operating procedures, work instructions, or policies.- Identify relevant guidance documents, international standards, or consensus standards and provide interpretive assistance.- Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.- Obtain and distribute updated information regarding domestic or international laws, guidelines, or standards.- Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures.- Develop and maintain product regulatory requirements and documentation templates to support submissions- Establish procedures or systems for publishing document submissions either in hardcopy or electronic formats- Evaluate new software publishing systems and confer with regulatory agencies concerning news or updates related to electronic publishing of submissions- Prepare, compile and complete submissions to FDA and EU regulatory entities- May perform other duties as required or assigned. Position Requirements- M.S. in Biochemistry, Microbiology, Molecular Biology or related field with a minimum of 5 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 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 detailPersonal 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 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, 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.Job ID US/CA00349 Country United States Location(s) Germantown, MD Department QA / QC / Regulatory Affairs Employment Type Regular Full-Time

Keywords: QIAGEN, Germantown , Senior Specialist Regulatory Affairs, Other , Germantown, Maryland

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