Regulatory Affairs - REACH Projects
Medical Device – Permanent Role
Location – North Midlands, commutable from Longford, Cavan, Roscommon, Westmeath.
Join this global healthcare provider in supporting and leading regulatory affairs in relation to new projects within their third party manufacturing programs.
Do you have the following experience?
- 5 years’ experience in a regulated industry GMP Environment
- Have you worked in regulatory affairs for a minimum of three years?
- Do you have prior experience working in EU and other international medical device regulations and submissions?
- Do you have experience working in a broader enterprise/cross-division business unit model preferred?
- Certification in Regulatory Affairs preferred.
What will you be doing in the role on a day-to-day basis.
- Provide Regulatory input to Design Plan cross functional teams: evaluate proposed changes for regulatory impact.
- Review and approve study protocols and records that which will from part of Regulatory submissions.
- Work with the Medical Writing group in coordinating activities related to the preparation and compilation of data and information into a comprehensive package for regulatory submissions, ensuring tasks are completed on time.
- Issue Notifications of Change to Notified Body and / or country affiliates as appropriate.
- Coordinate with manufacturing sites, third party manufacturers and countries to ensure all necessary documentation is provided to facilitate timely completion of Regulatory submissions & acquisition of approvals.
- Ensure compliance with product post - marketing approval requirements.
- Ensure external communications meet regulations.
- Supports all business segment initiatives as identified by management and in support of Quality Management Systems (QMS) and other regulatory requirements.
For a confidential discussion, reach out to Aisling Murray on 087 4671309