We’re looking for an RA Specialist to join us our Global Registrations team, either based out of Newcastle or working remotely from home. This is an excellent role for either a recent Graduate with a desire to work in Regulatory Affairs, or someone who has some existing experience.
This position will support with the registrations globally as required by the entire LBS business portfolio, facilitate product market withdrawals, collaborate closely with relevant health authorities, facilitate product registration renewals and handle submissions to support global registrations. Assist with Global Regulatory Intelligence.
In this role, you’ll
Assist with product registrations in one of the following territories: EU, Middle East and Africa
Responsible for registration, notification and assist in file preparation of the entire LBS product portfolio according to local regulatory requirements, where appropriate
Review and provide input into STED/CSTD/Tech Files.
Handle, supervise and promote continuous improvement activities through the use and implementation of DBS tools to ensure processes are evaluated constantly for efficiency.
Assist with Global Regulatory Intelligence and input into regulatory newsletter.
Liaison with SU, legal and Regulatory Bodies as required.
What you’ll need to do the job
Bachelor’s degree in science, medical or technical field.
Some knowledge of Quality or Regulatory Affairs, preferably medical device or IVD preferred.
High level of integrity.
Strong communication skills
Ability to multitask.
Ability to apply general scientific and quality knowledge to optimally complete assigned tasks to a high level.
Interested? Join the Leica Bio Systems Team!
Want to join our growing team that is helping our customers do incredible work? We look forward to your application!
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