My client, a well-established company in the healthcare industry, is looking to hire a Regulatory Affairs Specialist to join their growing company. This is a new and exciting role! The ideal candidate will have 1+ years of experience in regulatory affairs, quality or documentation and will have a relevant qualification in science, engineering or quality.
Responsibilities: (full job description available on request)
- Create and maintain audit friendly product file for customers and HPRA assurance
- Analysis of product compliant or non-compliance with regulatory requirements
- Research of alternative EU based suppliers
- Evaluate changes to manufacturing and supply chain processes
- Approve product labels, package inserts and marketing material
- A minimum of a degree in a Quality/Engineering/Science or related discipline is a MUST
- At least 1 years’ experience in a medical device/healthcare industry in a regulatory or quality position
- Must have very strong Technical Writing ability
- Must have good understanding of ISO 13485 and FDA QSR quality standards
- Excellent verbal and written communication skills
- Excellent attention to detail skills
- Must have the ability to work on own initiative, be able to work to targets and also as part of a team
For a confidential discussion and more information on the role, please contact Niamh Cregg.