Regulatory Affairs Manager Medical Devices EU
vor 3 Wochen
We are seeking a highly skilled Regulatory Affairs Manager to join our team at Merz Aesthetics GmbH. As a key member of our regulatory affairs department, you will play a crucial role in ensuring compliance with EU regulations for medical devices.
Key Responsibilities- Prepare and submit applications for conformity assessment and clinical trials of non-active implantable medical devices in the EU.
- Compile and update CE-dossiers for registrations and clinical trial applications.
- Provide expert advice on quality, analytical methods, pre-clinical, and clinical development to ensure acceptance of data in the EU.
- Contribute to the assessment of dossiers from third-party vendors.
- Assist in the preparation and update of product information texts according to company core data and relevant guidelines.
- Maintain and update the CE mark for our medical devices.
- Prepare and submit applications for renewals, change notifications, and annual updates in a timely manner.
- Contribute to the regulatory assessment of changes proposed by production centers, marketing departments, and other stakeholders.
- Coordinate regulatory projects and communicate with third-party vendors, consultants, and distribution partners.
- Manage regulatory consultants and develop regulatory strategies.
- Participate in project teams and act as the primary contact for regulatory requirements.
- Support the conduct of due diligence for established products with regards to regulatory aspects.
- Natural scientific background (pharmacist, biologist, chemist, etc.) with approbation, diploma, master degree, or PhD.
- Approximately 1 year of experience in EU regulatory affairs for medical devices.
- First-hand knowledge of the European regulatory landscape.
- Strong networking abilities with internal and external partners, including health authorities.
- Knowledge of relevant methods and analytical thinking.
- Structured work approach and business fluency in English, with additional languages a plus.
Merz Aesthetics GmbH is an international company in the field of aesthetic medicine, with a broad product portfolio synonymous with top quality in each category. As part of the Merz Group, we have our EMEA headquarters in Frankfurt am Main, Germany, and a global head office in Raleigh, North Carolina, USA. Our team of over 2,500 employees in 26 countries is committed to restoring and maintaining the skin's beauty.
We offer a dynamic work environment with flat hierarchies and short decision-making paths. Our employees enjoy a range of benefits, including company day care centers, flexible working time models, and ongoing training opportunities. We are committed to putting people first and fostering a culture of work-life harmony.
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Regulatory Affairs Specialist Medical Devices EU
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Regulatory Affairs Manager Medical Devices EU
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Frankfurt am Main, Hessen, Deutschland Merz Aesthetics GmbH VollzeitAbout the PositionWe are seeking a highly skilled Regulatory Affairs Manager to join our team at Merz Aesthetics GmbH. As a key member of our regulatory affairs department, you will play a crucial role in ensuring compliance with EU regulations for medical devices.Key ResponsibilitiesPrepare and submit applications for conformity assessment and clinical...
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Regulatory Affairs Manager Medical Devices EU
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Frankfurt am Main, Hessen, Deutschland Merz Aesthetics GmbH VollzeitAbout the PositionWe are seeking a highly skilled Regulatory Affairs Manager to join our team at Merz Aesthetics GmbH. As a key member of our regulatory affairs department, you will play a crucial role in ensuring compliance with EU regulations for medical devices.Key ResponsibilitiesPrepare and submit applications for conformity assessment and clinical...
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Frankfurt am Main, Hessen, Deutschland Merz Aesthetics GmbH VollzeitAbout the PositionWe are seeking a highly skilled Regulatory Affairs Manager to join our team at Merz Aesthetics GmbH. As a key member of our regulatory affairs department, you will play a crucial role in ensuring compliance with EU regulations for medical devices.Key ResponsibilitiesPrepare and submit applications for conformity assessment and clinical...
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Regulatory Affairs Manager Medical Devices EU
vor 4 Wochen
Frankfurt am Main, Hessen, Deutschland Merz Aesthetics GmbH VollzeitAbout the PositionWe are seeking a highly skilled Regulatory Affairs Manager to join our team at Merz Aesthetics GmbH. As a key member of our regulatory affairs department, you will play a crucial role in ensuring compliance with EU regulations for medical devices.Key ResponsibilitiesPrepare and submit applications for conformity assessment and clinical...
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Regulatory Affairs Manager Medical Devices EU
vor 3 Wochen
Frankfurt am Main, Hessen, Deutschland Merz Aesthetics GmbH VollzeitAbout the PositionWe are seeking a highly skilled Regulatory Affairs Manager to join our team at Merz Aesthetics GmbH. As a key member of our regulatory affairs department, you will play a crucial role in ensuring compliance with EU regulations for medical devices.Key ResponsibilitiesPrepare and submit applications for conformity assessment and clinical...
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Regulatory Affairs Manager Medical Devices EU
vor 3 Wochen
Frankfurt am Main, Hessen, Deutschland Merz Aesthetics GmbH VollzeitAbout the PositionWe are seeking a highly skilled Regulatory Affairs Manager to join our team at Merz Aesthetics GmbH. As a key member of our regulatory affairs department, you will play a crucial role in ensuring compliance with EU regulations for medical devices.Key ResponsibilitiesPrepare and submit applications for conformity assessment and clinical...
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Frankfurt am Main, Hessen, Deutschland Merz Aesthetics GmbH VollzeitAbout the PositionWe are seeking a highly skilled Regulatory Affairs Manager to join our team at Merz Aesthetics GmbH. As a key member of our regulatory affairs department, you will play a crucial role in ensuring compliance with EU regulations for medical devices.Key ResponsibilitiesPrepare and submit applications for conformity assessment and clinical...
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