Director - Regulatory Affairs (Companion

hace 1 semana

En remoto, España Qiagen A tiempo completo

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 6000 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 Translational Science and Precision Diagnostics (TSPDx) Regulatory Science team at QIAGEN fulfills a global function, working with and advising Companion Diagnostic (CDx) and other product development teams, developing and delivering competitive and innovative regulatory strategies, preparing regulatory submissions for the relevant countries, and supporting change control processes.

An exciting new opportunity has arisen for an experienced Regulatory Affairs professional to take on a Director role within QIAGEN's Global Regulatory Science team.


Key responsibilities:

  • Serve as Regulatory Science Lead for individual products and projects, developing and directing competitive and innovative regulatory strategies and ensuring regulatory compliance through the product life cycle for in vitro diagnostic (IVD) and CDx devices, components and accessories from feasibility to approval.
  • Preparing, submitting and managing FDA submissions (PMA's/ IDE's/ PMA Supplements/ Presubmissions).
  • Create technical documentation (IVDR) and International Registration Dossiers including Health Canada and PMDA.
  • Interact with external stakeholders on regulatory issues to support CDx development and commercialization of products.
  • Review partnership proposals and contracts to identify critical development and regulatory submission milestones, risks and opportunities.
  • Support other QIAGEN functions in customer facing issues involving Regulatory Affairs aspects. Navigate complex topics regarding country specific regulations, guidelines, and precedents. Keep abreast of changing regulatory landscape; analyze and share information with stakeholders. #LI-Remote

Position Requirements

  • Ideally 510 years' experience in regulatory affairs, including minimum 3 years in a team leadership role, for IVD companies, including successful premarket submissions.
  • Proven experience working with CDx products from a Regulatory Affairs perspective.
  • Significant experience in a regulated industry, with proven experience in Regulatory Affairs preparing PMA submissions and EU IVDR Technical Documentation.
  • Good working knowledge of the US medical device (IVD), IVDR, and applicable ISO standards regulations.
  • Ability to work on complex problems and exercise sound sciencebased decision making in developing regulatory strategies and solutions to regulatory problems.
  • Demonstrated organizational, planning, and prioritizing abilities, as well as strong technical writing ability.
  • Ability to work collaboratively in crossfunctional teams and to convey complex regulatory requirements in a straightforward and practical manner with employees at all levels of the organization, 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.

We offer:

  • Possibility to develop in an international company
  • Attractive pension
  • Private Healthcare
  • Private Dentalcare
  • Gym membership contribution
  • Access to an Employee Assistance Programme
  • A range of retail discounts and offers
  • Opportunity to join internal QIAGEN communities
  • Enhanced maternity package
  • Flexible working options
  • Bonus/commission
  • 25 days annual leave (potential to increase linked to service)
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, nat

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