Manager – Regulatory Affairs - Wrocław, Polska - QIAGEN

Opis

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 Syndromic Regulatory Affairs team at QIAGEN fulfill a global function, working with and advising infectious disease product development teams, 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 Management role.

Key responsibilities:

Participate on project development teams and support project and product teams from a regulatory perspective.

Prepare, submit and manage FDA in vitro diagnostic (IVD) product submissions (510(k)/De Novo/Pre-submissions).

Create technical documentation (IVDR) and International Registration Dossiers including Health Canada.

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 issues.

Position Requirements

Experience in a regulated industry, with proven experience in Regulatory Affairs preparing US FDA 510(k) submissions and EU Technical Documentation.

Good working knowledge of US medical device (IVD) regulations, IVDR, and applicable ISO standards.

Ability to work on complex problems and exercise sound science-based decision making in developing regulatory strategies and solutions to regulatory problems.

Ability to work collaboratively in cross-functional 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, national origin, religion, sexual orientation, gender identity, status as a veteran, or disability.