Posted on Jan 6, 2022 by Real Staffing Group
My client is a is a global healthcare leader that helps people live more fully at all stages of life. Their portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines.
They are currently seeking for a RA Manager to join their team in Galway.
The RA Manager will work as part of the Regulatory Affairs department with direct responsibility for developing regulatory plans with high level of complexity.
The successful person will plan and prepare documentation for international and domestic product registrations for new and modified products.
This role is currently fully remote but will be hybrid in the foreseeable future.
- Provides regulatory support for diagnostic product development and commercial diagnostic products
- Develops regulatory strategies for products in development and for modified products to achieve clearance/approval in the US and internationally
- Researches scientific and regulatory information in order to write, edit, and review submission documents
- Compiles and publishes all material required for submissions, license renewals, and annual registrations
- Works with governmental regulatory agencies and other third party accrediting bodies
- Maintains approvals/licenses/authorizations for existing marketing authorizations
Skills and Experience required:
- Bachelor's degree (BS/BA) in any scientific field.
- 3-5 years experience in Regulatory Affairs within a Senior Specialist role
- Knowledge of quality systems in a regulated manufacturing environment
If this role is of intrest please apply below for immediate consideration.
Not sure yet get in touch with myself on for a confidential conversation.
Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales