Regulatory Affairs Manager – with a focus on 510(k) submissions in Lübeck bei Dräger

Regulatory Affairs Manager – with a focus on 510(k) submissions (m/f/d) in Lübeck bei Dräger

Dräger

You convince people through your professional approach? Apply this professionalism successfully by achieving effective, expeditious product approvals and ensure compliance with external regulatory requirements. - Drägerwerk AG & Co. KGaA - Job-ID V000007742
Lübeck
Vollzeit

The Job Responsibilities

As a Dräger Regulatory Affairs Manager – with a focus on 510(k) submissions (m/f/d) you will participate in the preparation and processing of national and international marketing authorization applications and applications for amendments and renewals while considering regional requirements; this includes identifying the global regulatory requirements for your assigned product in a portfolio of either anesthesia, respiratory care or thermal therapy equipment.
One of your core tasks will be developing an approval strategy for the product in close coordination with project team members and FDA, representing the regulatory strategy and preparing the regulatory dossier for the USA. To achieve this, you will closely coordinate your activities with the project as well as FDA.
You are competent in regulatory requirements, you supervise the international approval procedures for the approval project, and you maintain contacts with international partners.
You will work closely (consultation and coordination of measures) with subject matter experts in various departments, as well as our company’s international subsidiaries, informing them proactively about FDA requirements and supporting necessary implementations in the product-specific documentation.

Your Qualifications

University degree (college of applicable science/university) with technical or scientific orientation
Several years of experience in regulatory affairs with active medical devices
Comprehensive knowledge of international approvals processes, in-depth knowledge of the US FDA Premarket Notification 510(k) approval requirements; knowledge of the US FDA Premarket Approval (PMA)
Regulatory Writing skills
Knowledge of QM systems (ISO 13485, 21 CFR part 820), MDR, international approval requirements in the field of medical technology and in related fields if applicable
Very good MS Office skills as well as fluent business German and English in word and writing
Your personal strengths include the ability to work in a team, organizational skills, communication skills, negotiation skills, the ability to present complex issues in a comprehensible manner and to work out solutions

The Dräger Workplace

Around 5,300 people work for Dräger in Lübeck. It's a great place to live. The second largest city (220,000 inhabitants) in Schleswig-Holstein offers a high quality of living, short commutes and many cultural and leisure activities. From here, you can visit the Baltic Sea in 20 minutes and Hamburg in just one hour. Our headquarters in Moislinger Allee is surrounded by greenery and water. Historical buildings mixed with modern architecture make up our main campus. From here, you can reach the historic down town (UNESCO World Heritage Site) and the main train station in just ten minutes on foot.

Who we are

From hospitals to fire departments to industrial customers, people around the world rely on our products: cutting-edge technology that combines real engineering with the digital future. With over 130 years of experience, passion and the bold ideas of more than 16,000 employees, we are committed to turning technology into ›technology for life‹.

What we offer