- Combining scientific, regulatory and business expertise to enable devices that are developed, manufactured and distributed to meet required legislation.
- Providing global regulatory strategy and direction to achieve early device market access in support of business objectives for EU class IIa and III devices.
- Developing and supervising a global team of regulatory professionals
- Overseeing changing regulations and guidance, interfacing with outside regulatory agencies and trade associations and providing executive management with regulatory metrics/information.
- Identifying and presenting regulatory strategy risk mitigation options to decision makers
- Overseeing processes involved with maintaining annual licenses and registrations
- Review and approval of labeling to ensure compliance
- Influencing design processes to drive clinical claims development early in the development process.
- Moderate to expert knowledge of diagnostic ultrasound and its clinical utility
- Experience with sterile devices including GMP, GCP, sterilization, packaging, and clean room environments.
- Superior presentation skills when communicating with all levels of the organization, business partners, and external sources.
- Global level influencing and are recognized as an expert resource both internally and externally.
- Providing effective leadership without direct authority.
- 8+ years of regulatory experience in medical devices and expertise with global medical device regulations and registration processes, especially USA, EU and China.
- BS/MS degree or equivalent experience. Related engineering, science, regulatory or medical/clinical disciplines preferred.
- Ability to manage multiple responsibilities with a high degree independence
- Strong organizational, negotiating, and problem-solving skills
- Excellent written and oral English communication skills; demonstrated public speaking skills
- Proven ability to interact successfully with all levels of the organization
- Willing to travel up to 20%
Organization: Siemens Healthineers
Company: Siemens Medical Solutions USA, Inc.
Experience Level: Experienced Professional
Job Type: Full-time
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