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Ra Officer
3 months ago
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.
The RA Officer Post Market Sustainment for Leica Biosystems is responsible for elements of the site regulatory obligations, including specialised responsibilities in Adverse Event reporting (MDR, Vigilance, HHE), communications with regulatory bodies, recalls and field actions, Post Market Surveillance and Complaints.
This position is part of the Quality and Regulatory Department located in Newcastle Upon Tyne and will be a hybrid working role.
You will be a part of the of the Quality and Regulatory team and report to the Post Market Sustainment RA Manager.
If you thrive in a multifunctional, fast paced role and want to work to build a world-class Quality organisation—read on.
In this role, you will have the opportunity to:
- Generate and maintain Post -market data for review and assist in the presentation of data to the appropriate teams
- Process customer complaints through evaluation and investigation to closure, determine if they are reportable to Regulatory Authorities
- Make safety and filing decisions for routine matters. Collaborate with management and medical affairs for nonroutine or serious events.
- Assist in conducting Field Actions, including submission of authority reports as required
The essential requirements of the job include:
- Bachelor's degree in science, medical or technical field and experience with increasing responsibility in medical device Regulatory Affairs
- Ability to identify and assess patient and user risk
- Strong organizational skills and ability to multitask
It would be a plus if you also possess previous experience in:
- Experience in the IVD field
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.
If you've ever wondered what's within you, there's no better time to find out.
