Quality and regulato....
Quality and regulatory affairs specialist
Posted on :
18-01-2024
Employer Active
1 Vacancy
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Job Description
Req ID : 2461824
For one of our clients specialised in invitro diagnostic product based in Cambridge and as part of a major international group we are looking for a Quality and regulatory affairs specialist.
As Quality and regulatory affairs specialist your main role will be to oversee supporting the initiation and the maintenance of the invitro diagnostic product registration and you will be responsible for the post market surveillance and vigilance activities.
Your main tasks are as follows:
Finally the successful candidate is recognised for good interpersonal skills with the ability to work across teams and the ability to take a riskbased approach in decision making.
As Quality and regulatory affairs specialist your main role will be to oversee supporting the initiation and the maintenance of the invitro diagnostic product registration and you will be responsible for the post market surveillance and vigilance activities.
Your main tasks are as follows:
- Providing the preparation of high quality first time ready technical documentation for submissions as well as responses to Notified Body and relevant Competent Authorities
- Support the review and approval of product labelling and promotional material
- Support regulatory compliance responsibility for post market activities including providing support to our distribution partners and ensure that appropriate vigilance processes and timelines are met
- Ensuring the quality management system is maintained and updated as appropriate
- Develop and continuously evaluate quality systems and make quality and operational improvements as needed through the management and change control systems to comply with the regulatory needs in EU markets.
Finally the successful candidate is recognised for good interpersonal skills with the ability to work across teams and the ability to take a riskbased approach in decision making.
Employment Type
Full Time
Key Skills
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