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Danaher Corporation Senior Regulatory Affairs Specialist (m/f/d) in München, Germany

Wondering what’s within Beckman Coulter Diagnostics? Take a closer look.At first glance, you’ll see that for more than 80 years we’ve been dedicated to advancing and optimizing the laboratory to move science and healthcare forward. Join a team where you can be heard, be supported, and always be yourself. We’re building a culture that celebrates backgrounds, experiences, and perspectives of all our associates. Look again and you’ll see we are invested in you, providing the opportunity to build a meaningful career, be creative, and try new things with the support you need to be successful.

Beckman Coulter Diagnostics is proud to work alongside a community of six fellow Diagnostics Companies at Danaher. Together, we’re working at the pace of change to improve patient lives with diagnostic tools that address the world’s biggest health challenges.

Working within the Q&RA organization, the Senior Regulatory Affairs Specialist (m/w/d) will support the 2 business units: Software System & Automation and Clinical Informatics. Do you want to thrive in a multifunctional, fast paced and central role? You will ensure product compliance in alignment with corporate requirements and report to the Regulatory Affairs Manager.

Responsibilities:

  • Deploy regulatory affairs strategy for product and processes in alignment with Quality Management System.

  • Handle pre-market and post-market activities in compliance with BEC process.

  • Ensure product compliance in order to support Business units strategy and requirements.

  • Interact and collaborate with BEC global counterparts, GPOs in order to improve processes.

In addition to the above responsibilities, you will contribute to the following activities:

  • Product design and registrations

  • Complaint investigation

  • Risk management

  • Post market surveillance including communication with relevant agencies and notified bodies

  • Networking with regulatory trade associations

  • RA intelligence

    Requirements and Qualifications:

  • Master´s degree in Science field with proven experience.

  • Medical Device background is required.

  • Demonstrated Regulatory Affairs expertise in Medical Device area for both pre and post-market activities.

  • Excellent knowledge of Medical Device Regulations. As minimum EU and MDSAP countries.

  • Excellent organizational skills.

  • Ability to quickly establish credibility and trustworthiness with key stakeholders.

  • Ability to create followership.

  • Fluent English is mandatory.

  • Position based in Munich, travel needs up to 10%.

We offer:

  • Modern, virtual working approach in an exciting international environment

  • Locations in the beautiful Munich area, close to public transportation

  • Flexible working hours and hybrid working where possible

  • Regular career and development cycles as well as salary reviews and a bonus system

  • Active Diversity & Inclusion Council to ensure an inclusive work environment, equal opportunities and pay

  • Company Pension Plan

  • Contribution to the costs of the job-ticket of the public transportation of Munich

Development: Danaher is a company that believes in continuous improvement — it is at the core of how we lead and operate our businesses. Whether refining our processes, our tools, or our products, the theme of evolution and getting better is fundamental to our DNA.

When you join the team, we will support your early days with a structured onboarding plan and a peer will support you throughout the onboarding phase. You are not left alone.

By joining Beckman Coulter, you will have access to our great internal training courses and be part of our Development for Growth Program.

You will also enjoy the advantages of the internal job platform, Danaher Go.

Well Being Program: We want you to be at your best both on and off the job. This means not only rewarding you for your contributions to our organization, but also providing the support you need to live a happy, healthy, fulfilling life outside of work.

Should your life get out of balance, the free Employee Assist Program (EAP) is available to you in the areas of questions about handling stress, maintaining relationships, dealing with work-related issues, coping with loneliness and improving communication.

When you join us, you’ll also be joining Danaher’s global organization, where 80,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System (https://www.danaher.com/how-we-work/danaher-business-system) tools and the stability of a tested organization.At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.If you’ve ever wondered what’s within you, there’s no better time to find out.

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