Regulatory Affairs Officer

2 weeks ago

Newcastle upon Tyne, United Kingdom Leica Biosystems Full time

Global Regulatory Affairs Officer - Hybrid - Newcastle

Leica Biosystems’ mission of “Advancing Cancer Diagnostics, Improving Lives” is at the heart of our corporate culture. We’re a global leader in cancer diagnostics with the most comprehensive portfolio from biopsy to diagnosis. Our easy-to-use and consistently reliable offerings help improve workflow efficiency and diagnostic confidence.
Our associates know that every moment matters when it comes to cancer diagnostics. When you come to work, you’re helping develop solutions that enable accurate diagnoses to turn anxiety into answers. Join our diverse, global team of talented people, and be inspired to grow every day.

Leica Biosystems 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.

This is a global regulatory position with responsibilities to support all Leica Biosystems Business Units and Selling Units in the EMEA region.

Major Responsibilities

**Country registrations**: responsible for product registrations for the assigned countries within EMEA region

**Regulatory intelligence**: responsible for gathering and keeping up-to-date the regulatory intelligence of the assigned countries within EMEA region

**UK and Switzerland regulation**: responsible for regulatory update in UK and Switzerland; perform the UKRP tasks as assigned; manage the Swiss Representative and Swiss Importer

**Vigilance**: participate and cooperate in the global Vigilance process, provides the vigilance reporting requirements for the assigned countries within EMEA region
Manage registration projects, use Visual Daily Management and other necessary DBS tool for communication and problem solving

Required Skills/Experience/Education
Bachelor’s degree in science, medical or technical field
Graduate or advanced degree preferred
Extensive experience in the IVD or medical device regulatory affairs and quality assurance
Relevant Medical device regulatory affairs certifications is a plus
Experience with IVDR, and/or MDR,
Experience with UKCA marking and Swiss regulations
Experience with regulatory submissions and registrations
Competencies
Ability to work independently
Ability to learn and adapt quickly
Strong organizational and communication skills. Ability to explain difficult or sensitive information. Works to build consensus.
Strong writing skills and ability to use appropriate software tools to develop and edit documents, procedures, reports.
High level of integrity
This role will be Hybrid with 2 days per week at our Newcastle office

At Leica Biosystems 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 Leica Biosystems can provide.

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 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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