Are you a regulatory affairs, compliance or quality professional within the medical device field who is keen to work for a leading global company in their field who continue to grow by around 10%+ year on year. This is an opportunity for a regulatory affairs coordinator to join a company that has a presence in 100+ countries globally and are looking to strengthen their regulatory and compliance team with this addition to their headcount.
The role works closely with their regulatory compliance manager and will involve providing support for the maintenance of all technical files and the assistance in achieving compliance for all products.
As the regulatory affairs coordinator your duties will include:
- Maintenance of technical files and all relevant documentation
- Assessing product compliance and associated risks
- Helping to develop the internal audit procedures
- Identifying areas of non-conformity and raising them through the relevant channels
- Supporting other departments (quality, technical.) during external audits
To apply for the regulatory affairs coordinator role, you will need:
- Experience of working within the regulatory, compliance or quality department of a medical device organisation
- A degree-level qualification in a relevant field (Medical Engineering, Biotechnology, Biomedical Science, Biological Sciences, Biology, etc.)
- Knowledge of relevant standards such as ISO13485, ISO14971 and MDD
- Experience of dealing with technical files
In return, the regulatory affairs coordinator will receive a competitive salary dependent on experience + pension and flexible benefits package.
The regulatory affairs coordinator role would suit someone who is a regulatory compliance engineer, regulatory compliance technician, quality engineer, quality technician, compliance engineer, compliance technician.
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