REGULATORY SPECIALIST - SOUTH EAST
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- Client ID:
- Posted on:
WEXFORD , WATERFORD
- Job type:
- Ensure continuous compliance
- Assist with regulatory submissions
- Assist with preparation and closing activities
- Process customer notification and regulatory requests
-Support Quality system and regulatory system improvements activities
- Support, Maintain and Develop document control system through
- Conduct Regulatory Audits
- Training of internal personnel on audit techniques
- Conduct Internal Audits
- Drive improvements in Internal audit process and prepping auditors
- Maintain of Internal audit documentation
- Keep up to date with current Regulatory requirements for e.g. FDA, E.U., Japan
- Carry out Regulatory audits to ensure fulfilment of requirement for Design and Development scope
- Assistance with management of issues and queries as they arise
- A minimum of 1-3 years’ experience in a quality assurance role in the pharmaceutical, healthcare or medical device sector essential, preferably in an FDA regulated environment
- 3rd Level Qualificationwith Engineering or science degree or equivalent experience.
- Qualified systems lead auditor an advantage
- Strong planning, coordination and organisational skills
- Strong attention to detail.
- Experience working with USA regulatory requirements an advantage.
Hartley People Recruitment work to the highest ethical standards within our industry and we value the trust that you place in us when you send your CV. We can provide a full consultation in confidence and we guarantee that your CV will not be sent to any of our clients without your prior consent.
For immediate consideration please callSara on 051-878813 or email your CV in response to this job posting.
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