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Head Global Product Safety - Aesthetics
at Merz USA
As Head of Global Product Safety - Aesthetics you will ensure the safety and performance of all global medical devices, under development or marketed, by maintaining and expanding a worldwide state-of-the-art medical device vigilance system and post market surveillance system. You continuously challenge and optimize existing processes; support the implementation of technical solutions to permanently monitor the safety profiles of medical devices with aesthetic purposes; and efficiently manage risks on a global level.
- Maintain and expand the state-of-the-art Medical Device Vigilance System for the entire Merz Aesthetic business on a global level.
- Ensure compliance regarding expedited and periodic reporting of safety information and adverse events to authorities and Notified Bodies worldwide by incorporating compliant procedures throughout the organization and in line with industry standards and best practices.
- Ensure the availability of legally required functions for legal manufacturer and CE mark holder as appropriate, e.g. an EU representative or the person responsible for regulatory compliance.
- Effectively collaborate with global stakeholders outside of Global Product Safety Aesthetics, including Clinical, Regulatory Affairs, Legal, Medical Affairs, and Quality/Manufacturing.
- Successfully manage interfaces with Merz Therapeutics by ensuring that all safety-relevant information regarding Merz Aesthetics’ drugs is properly collected and timely forwarded.
- Ensure that contractual arrangements for the exchange of a safety relevant information with affiliates and commercial partners worldwide are in place.
- Represent Merz Aesthetics with authorities, Notified Bodies and third parties in all safety-related questions regarding the medical devices of Merz Aesthetics.
- Provide optimal support of Merz Aesthetics development projects, ensuring the safety of our innovative Merz Aesthetics products by carefully monitoring safety from the initial stages.
Knowledge, Skills & Abilities:
- Minimum of a Medical Degree.
- At least 8 years of experience within the pharmaceutical/medical device industry with advancing responsibilities to more senior roles.
- At least 3-5 years of experience of implementing, maintaining and expanding a worldwide medical device vigilance and or post market surveillance system
- At least 3-5 years of experience in a senior leadership role within an international environment
- Excellent knowledge of national and international regulations governing medical device vigilance, e.g. ISO norms 13485, 14971, MEDDEV, and the upcoming Medical Device Regulation in the EU
- Experiences with inspections and audits by authorities and notified bodies
- Thorough understanding of the device development process and context applicable to safety
- Comprehensive understanding of product labeling and Instructions For Use.