Job Overview
We are seeking a Regulatory Affairs Specialist to support new product development teams, ensuring compliance with regulatory requirements and enabling successful product launches.
Main Responsibilities:
* Provide regulatory guidance on new product development projects.
* Develop and maintain regulatory strategies for new and modified products.
* Prepare and implement regulatory filings, including technical files and submissions.
* Conduct international registrations in accordance with regulatory strategies.
* Support the setup and management of outside vendors.
* Perform change management activities, including reviewing and approving promotional materials.
* Provide input on and approve product labels and labeling.
* Support post-market surveillance and vigilance activities.
* Manage and maintain Regulatory Affairs internal policies and procedures.
Key Requirements:
* Bachelor's degree or equivalent experience in Analytical Chemistry, Biochemistry, or Biomedical Engineering.
* Regulatory affairs experience in the In Vitro Diagnostic Medical Device environment.
* Knowledge and application of 21 CFR 820 and ISO 13485.
* High proficiency in English, verbal and written.
Work Location: Wexford, IE ( Minimum 60% office time )