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Regulatory Affairs Medical Devices Expert
3 weeks ago
In this challenging and rewarding role, you will be responsible for ensuring the compliance of Abbott Nutrition medical devices with regulatory requirements. As a Medical Safety & Surveillance (MSS) Global Medical Device Manager, you will develop and implement global standardized operating procedures, as well as lead the development/maintenance of local medical device vigilance systems.
Your responsibilities will include generating documentation to support global medical device registration and ongoing compliance with the European Union Medical Device Regulation (EUMDR). You will work closely with cross-functional teams to maintain current knowledge of regulatory safety reporting guidelines and implement relevant guidelines into practices and procedures.
To succeed in this role, you will need a deep understanding of medical devices and regulatory requirements, as well as experience in generating documentation and managing complex projects. You will also need excellent communication and interpersonal skills, as well as the ability to work productively as part of a team.
- Develop and implement global standardized operating procedures for medical device registration and compliance.
- Lead the development/maintenance of local medical device vigilance systems to ensure compliance with local regulations.
- Generate documentation to support global medical device registration and ongoing compliance with EUMDR.
- Maintain current knowledge of regulatory safety reporting guidelines.
- Implement relevant guidelines into practices and procedures.
