Manager Regulatory Affairs

Employment Type

: Full-Time

Industry

: Miscellaneous



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.

Position Description

The key responsibilities of the position are to:

- Represent Regulatory Affairs on interdepartmental teams for projects with Operations, Development, QA, Marketing, and other functions as required.

- Manages IVD product strategies for submissions, registrations, and maintenance globally.

- Prepare regulatory submissions for US (e.g. 510k, PMA) and Health Canada (e.g. Class III) approvals for QIAGEN IVD products including reagents and instrumentation/software.

- Prepare technical documentation needed to demonstrate compliance with applicable European Directives.

- Interface with Regulatory Agencies for inquiries and issues.

- Represent Regulatory Affairs during management of the IVD product change process.

Position Requirements

- Minimum Bachelor’s Degree in a scientific discipline.

- Minimum 4 years’ experience in a regulated industry, with at least 2 years’ experience in Regulatory Affairs preparing US FDA 510(k) and/or PMA submissions, preferably IVD experience.

- Demonstrated organizational, planning and prioritizing abilities are required, 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.

Personal Requirements

- Good verbal and written skills, working knowledge of MS-Word, Excel and/or Access

- 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 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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