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Regulatory Affairs Manager Job Description
We are recruiting a Regulatory Affairs Manager to provide support to our pharmaceutical and medical device company. In this role, you will oversee regulatory submissions, ensuring they are compliant with regulations as well as the guidelines set by regulatory bodies. As part of this process, you will prepare and file submission documents. You will also assist with external audits and respond to any complaint documentation regarding our devices.
Regulatory Affairs Manager Responsibilities
- Prepare and file regulatory submissions
- Perform assessments of new or revised products
- Manage complaint documentation
- Perform or facilitate audits to ensure compliance
- Respond to enquiries from regulatory bodies
- Improve internal processes to reduce risk
- Collaborate with team members to obtain documentation
Regulatory Affairs Manager Requirements
- A bachelor’s degree in a technical field (required)
- Organisational and communication skills
- Regulatory experience in the industry (5-10 years preferred)
- Up-to-date knowledge of international and governmental guidelines
- A master’s degree in regulatory affairs a plus
- Sound judgement
- Attention to detail
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