Aktuelle Jobs im Zusammenhang mit Senior Regulatory Affairs Specialist - Freiburg - Stryker
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(Senior / Staff) Regulatory Affairs Specialist
vor 3 Monaten
Freiburg, Deutschland Stryker VollzeitAs a (Senior/Staff) Regulatory Affairs Specialist (M/F/d) at our Freiburg office, step into a dynamic role that not only demands excellence in regulatory affairs for our cutting-edge CMF business at Stryker but also offers an unparalleled learning opportunity. Harness your expertise to navigate regulatory landscapes, while immersing yourself in a culture of...
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Regulatory Affairs Specialist
Vor 3 Tagen
Freiburg, Baden-Württemberg, Deutschland Adaptive Business Group VollzeitAre you a seasoned Regulatory Affairs professional looking for a new challenge in the medical technology field?We're currently supporting a client in the medical device industry who are seeking a highly skilled individual to strengthen their team. Key Responsibilities:• Prepare and compile regulatory submissions for new medical device registrations and...
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Regulatory Affairs Specialist
Vor 2 Tagen
Freiburg, Baden-Württemberg, Deutschland Adaptive Business Group VollzeitAre you a seasoned Regulatory Affairs professional looking for a new challenge in the medical technology field?We're currently supporting a client in the medical device industry who are seeking a highly skilled individual to strengthen their team. Key Responsibilities:• Prepare and compile regulatory submissions for new medical device registrations and...
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Regulatory Affairs Specialist
Vor 3 Tagen
Freiburg, Baden-Württemberg, Deutschland Adaptive Business Group VollzeitAre you a seasoned Regulatory Affairs professional looking for a new challenge in the medical technology field?We're currently supporting a client in the medical device industry who are seeking a highly skilled individual to strengthen their team. Key Responsibilities:• Prepare and compile regulatory submissions for new medical device registrations and...
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Regulatory Affairs Specialist
Vor 3 Tagen
Freiburg, Baden-Württemberg, Deutschland Adaptive Business Group VollzeitAre you a seasoned Regulatory Affairs professional looking for a new challenge in the medical technology field?We're currently supporting a client in the medical device industry who are seeking a highly skilled individual to strengthen their team. Key Responsibilities:• Prepare and compile regulatory submissions for new medical device registrations and...
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Regulatory Affairs Specialist
Vor 3 Tagen
Freiburg, Baden-Württemberg, Deutschland Adaptive Business Group VollzeitAre you a seasoned Regulatory Affairs professional looking for a new challenge in the medical technology field?We're currently supporting a client in the medical device industry who are seeking a highly skilled individual to strengthen their team. Key Responsibilities:• Prepare and compile regulatory submissions for new medical device registrations and...
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Regulatory Affairs Specialist
Vor 3 Tagen
Freiburg, Baden-Württemberg, Deutschland Adaptive Business Group VollzeitAre you a seasoned Regulatory Affairs professional looking for a new challenge in the medical technology field?We're currently supporting a client in the medical device industry who are seeking a highly skilled individual to strengthen their team. Key Responsibilities:• Prepare and compile regulatory submissions for new medical device registrations and...
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Regulatory Affairs Specialist
Vor 7 Tagen
Freiburg, Baden-Württemberg, Deutschland neuroloop GmbH Vollzeit{"h1": "Senior Regulatory Affairs Manager", "p": "At neuroloop GmbH, we are pushing the boundaries of medical technology to develop innovative solutions for the treatment of chronic diseases. As a Senior Regulatory Affairs Manager, you will play a crucial role in ensuring the compliance of our medical devices with international regulations, such as the MDR...
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Regulatory Affairs Specialist
Vor 7 Tagen
Freiburg, Baden-Württemberg, Deutschland neuroloop GmbH Vollzeit{"h1": "Senior Regulatory Affairs Manager", "p": "At neuroloop GmbH, we are pushing the boundaries of medical technology to develop innovative solutions for the treatment of chronic diseases. As a Senior Regulatory Affairs Manager, you will play a crucial role in ensuring the compliance of our medical devices with international regulations, such as the MDR...
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Senior Regulatory Affairs Manager
vor 1 Tag
Freiburg, Baden-Württemberg, Deutschland neuroloop GmbH VollzeitSenior Regulatory Affairs ManagerWe are seeking a highly skilled Senior Regulatory Affairs Manager to join our team at neuroloop GmbH. As a key member of our regulatory affairs team, you will be responsible for ensuring the compliance of our medical devices with international regulations and standards.Key Responsibilities:Prepare and compile regulatory...
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Senior Regulatory Affairs Manager
vor 1 Tag
Freiburg, Baden-Württemberg, Deutschland neuroloop GmbH VollzeitSenior Regulatory Affairs ManagerWe are seeking a highly skilled Senior Regulatory Affairs Manager to join our team at neuroloop GmbH. As a key member of our regulatory affairs team, you will be responsible for ensuring the compliance of our medical devices with international regulations and standards.Key Responsibilities:Prepare and compile regulatory...
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Senior Regulatory Affairs Manager
Vor 3 Tagen
Freiburg, Baden-Württemberg, Deutschland interpool Personal GmbH VollzeitÜber unser UnternehmenUnser Kunde, interpool Personal GmbH, ist ein dynamisches Familienunternehmen mit Sitz in der Region Freiburg. Wir fördern eine Unternehmenskultur, die Verantwortungsbewusstsein, Vielfalt und Vertrauen schätzt.JobbeschreibungWir suchen einen Senior Regulatory Affairs Manager (m/w/d), der sich auf die Entwicklung von Produkten zur...
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Senior Regulatory Affairs Manager
Vor 3 Tagen
Freiburg, Baden-Württemberg, Deutschland interpool Personal GmbH VollzeitÜber unser UnternehmenUnser Kunde, interpool Personal GmbH, ist ein dynamisches Familienunternehmen mit Sitz in der Region Freiburg. Wir fördern eine Unternehmenskultur, die Verantwortungsbewusstsein, Vielfalt und Vertrauen schätzt.JobbeschreibungWir suchen einen Senior Regulatory Affairs Manager (m/w/d), der sich auf die Entwicklung von Produkten zur...
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Regulatory Affairs Specialist
Vor 4 Tagen
Freiburg, Baden-Württemberg, Deutschland i-Pharm Consulting VollzeitJob SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at i-Pharm Consulting. As a key member of our team, you will be responsible for contributing to the creation of technical documentation for existing and new medical devices, as well as implementing the global regulatory strategy.Key ResponsibilitiesDevelop and maintain...
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Regulatory Affairs Specialist
Vor 4 Tagen
Freiburg, Baden-Württemberg, Deutschland i-Pharm Consulting VollzeitJob SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at i-Pharm Consulting. As a key member of our team, you will be responsible for contributing to the creation of technical documentation for existing and new medical devices, as well as implementing the global regulatory strategy.Key ResponsibilitiesDevelop and maintain...
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Regulatory Affairs Specialist
Vor 4 Tagen
Freiburg, Baden-Württemberg, Deutschland i-Pharm Consulting VollzeitJob SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at i-Pharm Consulting. As a key member of our team, you will be responsible for contributing to the creation of technical documentation for existing and new medical devices, as well as implementing the global regulatory strategy.Key ResponsibilitiesDevelop and maintain...
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Regulatory Affairs Specialist
Vor 4 Tagen
Freiburg, Baden-Württemberg, Deutschland i-Pharm Consulting VollzeitJob SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team at i-Pharm Consulting. As a key member of our team, you will be responsible for contributing to the creation of technical documentation for existing and new medical devices, as well as implementing the global regulatory strategy.Key ResponsibilitiesDevelop and maintain...
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Leiter Regulatory Affairs
vor 1 Monat
Freiburg, Baden-Württemberg, Deutschland HAPEKO Deutschland GmbH VollzeitÜber HAPEKO Deutschland GmbH:HAPEKO ist die führende Adresse für Fach- und Führungskräfte in Deutschland. Wir schaffen Verbindungen zwischen talentierten Spezialisten und Unternehmen, die auf der Suche nach qualifizierten Mitarbeitern sind.Unternehmensprofil:Unser Klient ist ein Vorreiter in der Industrie- und Medizintechnik. Mit einem klaren Fokus auf...
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Leiter Regulatory Affairs
vor 1 Monat
Freiburg, Baden-Württemberg, Deutschland HAPEKO Deutschland GmbH VollzeitÜber HAPEKO Deutschland GmbH:HAPEKO ist der führende Ansprechpartner für Fach- und Führungskräfte in Deutschland. Unser Ziel ist es, Verbindungen zwischen talentierten Spezialisten und Unternehmen herzustellen, die auf der Suche nach qualifizierten Mitarbeitern sind.Unternehmensprofil:Unser Klient ist ein führendes Unternehmen im Bereich der Industrie-...
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Regulatory Affairs Specialist
vor 3 Wochen
Freiburg, Baden-Württemberg, Deutschland i-Pharm Consulting VollzeitJob Summary:We are seeking a highly skilled Regulatory Affairs Specialist to join our team at i-Pharm Consulting. As a key member of our Regulatory Affairs department, you will be responsible for ensuring compliance with global regulatory requirements for medical devices.Key Responsibilities:Develop and implement global regulatory strategies for medical...
Senior Regulatory Affairs Specialist
vor 4 Monaten
As the **Senior Regulatory Affairs Specialist (M/F/d),** your role involves collaborating on Stryker's **Spine** **portfolio for Global Regulatory release. This entails contributing to the development and updating of regulatory strategy based on regulatory changes. You will play a key role in supporting the product lifecycle through obsolescence, assessing changes made to the device post-launch to determine the regulatory impact on the current clearance.
Additionally, you will actively participate in cross-functional teams, formulate global regulatory strategies, author regulatory submissions, engage with regulatory agencies/notified bodies. This position is integral to supporting the Spine product portfolio, Spine navigation solution utilizing advanced software aimed at enhancing patient outcomes.
**What will you do**
- As the Senior Regulatory Affairs Specialist, you will assesses regulatory intelligence to assist in the development of local, regional, and global regulatory strategies.
- You will provide regulatory information and guidance for product development/ enhancement and planning throughout the product lifecycle to the regulatory groups and others within the organization.
- You will develop regulatory strategy and update strategy based upon regulatory and product changes
- You will evaluate the regulatory environment and contribute to providing internal advice throughout the product lifecycle (e.g., concept, development, manufacturing, marketing) to ensure product compliance.
- You will perform regulatory impact assessment of post-market changes with no supervision.
- You will identify the need for new regulatory procedures, SOPs, and participates in development and implementation.
- You will determine requirements (local, national, international) and options for regulatory submission, approval pathways, and compliance activities
**What will you need**
- You have completed BS in Engineering, Science, or related degree; or MS in Regulatory Science; RAC(s) is preferred.
- You have gained a minimum of 2 years’ experience in medical technology or another regulated sector in the area of quality or regulatory affairs. Medical Device regulatory affairs experience is preferred.
- You already have experienced working with ISO 13485 and 21 CFR 820 compliance
- Your English and German language(preferred) skills enable you to collaborate with colleagues and stakeholders on a global basis as well in the local office.
**Additional information**
Thanks to our flexible working hours model, you will have the opportunity to work partially from the home office. However, a regular presence on site at our location in Freiburg should be always given to build sustainable relationships and maintain personal contact with colleagues as well as the departments.
Please note that the internal job title may differ from the ad title.
**Your contact**:
**About Stryker**:
Stryker is one of the world’s leading medical technology companies and, together with our customers, is driven to make healthcare better.
The company offers innovative products and services in Medical and Surgical, Neurotechnology, Orthopedics, and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 100 million patients annually.
