Senior Manager, RA Processes, Systems and Tools

2 weeks ago

Copenhagen, Copenhagen, Denmark Radiometer Danmark Danaher Full time

In our line of work, life isn't a given - it's the ultimate goal. When life takes an unexpected turn, our technology and solutions enable caregivers to make informed diagnostic decisions to improve patient care. This is our shared purpose at Radiometer and what unites all +4000 of us - no matter our roles or where in the world we're located. Creating impactful innovations like ours doesn't happen overnight - it requires uncompromising persistency, passion, and a desire to make a difference. Here, you can learn, grow, and chart an uncommonly diverse career.

Radiometer 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 Senior Manager, RA Processes, Systems and Tools for Radiometer is responsible for driving process improvements as well as the implementation of systems and tools within Regulatory Affairs to support efficient regulatory support for the organization and growth of the company.

This position is part of the Global Regulatory Affairs team located primarily in Copenhagen, Denmark and will be an on-site position. At Radiometer, our vision is to improve global healthcare with reliable, fast, and easy patient diagnoses.

You will be a part of the Regulatory Affairs leadership team and report to the Sr Director Regulatory Affairs responsible for global regulatory strategy and tactical planning, providing guidance and support to the organization during product development as well as post-market and through market expansions globally with our product portfolio. The Regulatory Affairs team assures that defined regulatory strategies are effectively implemented and maintained in line with changing regulatory and business needs. If you thrive in an amazing, multifunctional, leadership, fast-paced, supporting role working with stakeholders across the global organization and want to work to build a world-class regulatory affairs team - read on.

In this role, you will have the opportunity to:

  • Oversee and direct an awesome team of highly engaged associates and focus on continuous development of the team.
  • Drive process improvements for RA owned processes and procedures.
  • Implement systems and tools that support the Regulatory Affairs organization towards a more efficient way of working.
  • Work with key stakeholders and a cross-functional team monitoring, interpreting, and implementing new/changed legislation, standards, and guidance through the Regulatory Intelligence process and other processes such as MAPSS (Marketing, Advertising, Promotional, Scientific, and Sales) material.
  • Establish and drive Daily Management in RA as well as the improvement opportunity funnel.

The essential requirements of the job include:

  • Minimum bachelor's degree in a technical field such as chemistry, biochemistry, biology, or related required.
  • Knowledge and experience in global IVD/MD regulations, quality standards such as ISO 13485, US FDA 21 Part 820, IVDR/MDR, design control, risk management, etc. required.
  • Minimum 7 years of regulatory experience related to medical device/in vitro diagnostics required.
  • Demonstrates excellent negotiation skills, problem-solving skills and builds consensus.
  • Demonstrates effective communication skills in written and oral channels both within Regulatory and across the organization.
  • Able to deliver challenging messages effectively without compromising important business relationships.
  • Experience working in a complex matrix environment.

It would be a plus if you also possess previous experience in:

  • Prior experience holding accountability and responsibility for global business metrics and application of data-based process improvements.

Application
We continuously assess candidates and invite them for interviews, so please don't hesitate to write and send in the application.

We encourage you to apply before end of business on 30th September 2024. If you have questions, feel free to contact Senior Director RA/QA, Quality and Regulatory Affairs, Maria Fagerberg at maria.fagerberg@hemocue.se. We look forward to seeing your application.

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