Regulatory Affairs Specialist

vor 3 Wochen

Munich, Deutschland Beckman Coulter Diagnostics Vollzeit

**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.

The **Regulatory Affairs Specialist (m/w/d)** for Beckman Coulter Diagnostics is responsible for the support of 2 business units: Software System & Automation and Clinical Informatics to ensure product compliance in alignment with corporate requirements.

This position is part of the Q&RA organization located in Munich and will be hybrid. At Beckman Coulter, our vision is to relentlessly reimagine healthcare, one diagnosis at a time.

You will be part of the Q&RA organization and report to the Regulatory Affairs Manager. If you thrive in a multifunctional, fast paced and central role and want to work to build a world-class Q&RA organization - read on.

**In this role, you will have the opportunity to**:

- Support the establishment of 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.
- Interact and collaborate with BEC global counterparts to manage Regulatory 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

**The essential requirements of the job include**:_ _**:

- Master´s degree in Science field
- Basic Medical Device background is required
- Demonstrated Regulatory Affairs expertise in Medical Device area for both pre and post-market activities (~2 years experience)
- Experience in IVD/MD registration in the US and EU
- Knowledge of Medical Device Regulations, with a focus on EU and MDSAP countries
- Ability to quickly establish credibility and trustworthiness with key stakeholders
- Fluent English is mandatory
- Position based in Munich, travel needs up to 10%.

At Beckman Coulter Diagnostics we believe in designing a better, more sustainable workforce. We recognize the benefits of flexible, hybrid working arrangements for eligible roles and are committed to providing enriching careers, no matter the work arrangement. This position is eligible for a hybrid work arrangement in which you can work part-time at the Company location identified above and part-time remotely from your home. Additional information about this hybrid work arrangement will be provided by your interview team. Explore the flexibility and challenge that working for Beckman Coulter Diagnostics can provide.

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.

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