Matrix Recruitment are seeking to recruit a Regulatory Affairs Project Manager for our multinational client, based in the Wexford region.
This is a very innovative site where they manufacture a wide array of products & Technology within the life science space.
***This role offers remote working/ with some onsite requirement for business needs***
This is a permanent job with some travel abroad for training…
Key duties & responsibilities:
- Responsible and accountable for regulatory support
- Primary focus on UDI, for operations, product development and quality to ensure that the product is in compliance with all regulatory requirements
- Regulatory Affairs Subject Matter Expert on UDI requirements globally
- Implement and maintain global UDI requirements and associated procedures for two company sites
- Train Regulatory Affairs & Quality System team members on UDI processes and systems
- Assist in the development and improvement of Regulatory processes and procedures
- Participates in product development/line extension teams as required
What are we looking for?
- Degree in Science or Engineering
- Minimum 4 years RA and/or Quality Systems experience
- Medical Device/Pharmaceutical or Life Science Industry experience
- Strong regulatory knowledge around guidelines, policies, principles and requirements of applicable product laws/standards
- Must be able to travel
- German knowledge an advantage
Apply for this job now by emailing your WORD formatted CV to Patricia.
Please note that due to the expected high volume of applications we can only reply to applicants suitable for the position. In the interest of protecting your data and informing you of your rights we will notify you should we retain your information by issuing an acknowledgement email and a request for consent where not already expressly given.
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