
Regulatory Affairs Specialist
1 week ago
Job Description:
We are seeking a motivated Regulatory Affairs Specialist to support our Diagnostics division. This role provides a wide range of activities across the Regulatory Department and is ideal for a proactive and resilient self-starter with excellent multi-tasking abilities and a high attention to detail.
Main Responsibilities:
- Assist in tracking and updating product submissions status
- Support the team in reviewing scientific content of new and product change registration packages
- Perform logistics functions associated with regulatory approval of products
- Assist in tracking and planning post-approval commitments
- Understand and assist in submitting medical incident reporting
- Review and approve advertising and promotional material
- Obtain and provide required quality documentation and regulatory advice for tenders
- Provide support for obtaining additional authorizations to support business needs
- Train internal customers in all aspects of regulatory
- Represent RA and collaborate with cross-functional departments to ensure regulatory requirements are met and integrated within the Quality system
Requirements:
This is an entry-level opportunity suitable for individuals with a science, biomedical or equivalent degree. Experience with regulatory and/or quality experience within the medical devices industry would be an advantage.
About Us:
We offer a close-knit team environment where we work towards providing insights that enable smarter and faster decisions to transform the way the world manages health.
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