ProClinical has a brilliant opportunity for a Vigilance Officer to be based in Germany. This job will be with one of the largest workforce management solutions companies in the world who specialise in multiple scientific and engineering sectors.
- To undertake vigilance activities to support PMS requirements.
- To aid with regulatory compliance in markets to which company medical devices will be introduced.
- To provide support with the application for the FDA 510(k) process.
- To provide assistance in the application of market specific QMS requirements e.g. ISO 13485, FDA 21 CFR Part 820 etc.
- To ensure that all standards associated with company medical devices are maintained to the latest issue.
- To provide support to the risk process (BS EN ISO 14971) for TF maintenance and FDA submission.
Skills and Requirements:
- A relevant degree, Masters or PhD involving a high level of research, data interpretation, and presentation preferably in Science or Engineering.
- Experience with the Medical Device Directive and the particular standards associated with Sterilisation of medical devices.
- Min. one year experience in working in medical device vigilance
- An ability to use general office software (Microsoft Office) and other specialised software (e.g. online resource tools and databases).
- Fluent in English, German is a plus
- Ability to communicate effectively, and credibly, with all colleagues and stakeholders (internal & external).
- Ability to analyse and understand data to enable decisions to be made objectively.
- Ability to follow instructions accurately and diligently.
- This is an assignment for initially 12 months and can be adjusted to a freelancer or a fixed term contract.
- Part time home office is possible.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Nick Dietz on +44 203 3193 033 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.