Specialist Regulatory Affairs (Senior)

at  Qiagen

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

• In partnership with EMEA RA Manager and Commercial Partners plan, prepare and co-ordinate the completion of EMEA market applications and submissions to EMEA Regulatory Authorities (i.e Turkey, Kazakhstan, Ukraine, Israel, Saudi Arabia, United Arab Emirates, Algeria) to secure product approvals for QIAGEN’s In vitro Diagnostic and Medical Device products.
• Effectively engage and collaborate with global third-party partners and distributors in support of worldwide regulatory registrations.
• Develop regulatory strategies to facilitate corporate global product registration objectives.
• Support internal and external stakeholders with regulatory guidance, regulatory documents and submission status information.
• Maintain a current knowledge base of existing and emerging EMEA regulations to assist in future product development and registration.
• Provides regulatory impact assessments for product/process/supplier changes.
• Maintain regulatory files and documentation in accordance with company policies and regulatory requirements.
• Provide training to Regulatory Affairs staff and business partners as required.

Position Requirements

• A Bachelor’s degree in a relevant field such as Science, Engineering, Pharmacy, or Life Sciences.
• Minimum 3 years of regulatory affairs experience in a medical device or vitro-diagnostic industry for EMEA region (Demonstrated knowledge and understanding of medical device regulations and delivery or co-ordination of successful medical device licence approvals in EMEA region).
• Fluency in English.
• Experience and understanding of regional regulatory requirements for medical devices, IVDs and CDx products.
• Prior experience in handling global regulatory projects and collaborating with global third-party partners and distributors.
• Experience in working effectively in a cross-functional team setting.
• Ability to communicate complex requirements clearly and in a timely manner to peers, internal, and external business partners.
• Proficient use of Microsoft Office products suite (e.g. Excel, Word, Outlook and PowerPoint) and experience with SAP, MasterControl and TrackWise.

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
• Training and development programs
• Private medical care
• Group Life Insurance
• Multisport card
• Flexible benefits platform
• Language classes
• Pension Scheme (PPE) after 12 months
• Childcare subsidy
• Happy Monday :)
• Friendly atmosphere
• Casual dress code
• Attractive location (Sky Tower)

Please refer the Job description for details