Aktuelle Jobs im Zusammenhang mit Regulatory Affairs Executive - Heidenheim an der Brenz, Baden-Württemberg - PAUL HARTMANN AG
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Regulatory Affairs Manager
vor 4 Wochen
Heidenheim an der Brenz, Baden-Württemberg, Deutschland PAUL HARTMANN AG VollzeitJob Title: Manager Regulatory AffairsWe support healthcare professionals, so they can focus on what really matters: positively impacting people's lives.About the RoleAs the Head of Regulatory Affairs within our Risk Prevention division, you will be a member of the Divisional Management Board, responsible for all regulatory requirements of our entire product...
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Regulatory Affairs Manager
vor 4 Wochen
Heidenheim an der Brenz, Baden-Württemberg, Deutschland PAUL HARTMANN AG VollzeitJob Title: Manager Regulatory AffairsWe support healthcare professionals, so they can focus on what really matters: positively impacting people's lives.About the RoleAs the Head of Regulatory Affairs within our Risk Prevention division, you will be a member of the Divisional Management Board, responsible for all regulatory requirements of our entire product...
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Regulatory Affairs Director
vor 1 Monat
Heidenheim an der Brenz, Baden-Württemberg, Deutschland PAUL HARTMANN AG VollzeitRegulatory Affairs ManagerAt PAUL HARTMANN AG, we're committed to helping healthcare professionals make a positive impact on people's lives. We're a company that values innovation, collaboration, and growth. As the Head of Regulatory Affairs, you'll play a key role in driving our regulatory strategy and ensuring compliance with all relevant standards and...
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Regulatory Affairs Director
vor 1 Monat
Heidenheim an der Brenz, Baden-Württemberg, Deutschland PAUL HARTMANN AG VollzeitRegulatory Affairs ManagerAt PAUL HARTMANN AG, we're committed to helping healthcare professionals make a positive impact on people's lives. We're a company that values innovation, collaboration, and growth. As the Head of Regulatory Affairs, you'll play a key role in driving our regulatory strategy and ensuring compliance with all relevant standards and...
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Regulatory Affairs Manager
vor 4 Wochen
Heidenheim an der Brenz, Baden-Württemberg, Deutschland PAUL HARTMANN AG VollzeitJoin Our Team as a Manager Regulatory Affairs ClinicalWe are seeking a highly skilled and experienced Manager Regulatory Affairs Clinical to join our global team at PAUL HARTMANN AG. As a key member of our regulatory affairs team, you will play a crucial role in ensuring the proper execution of procedures demonstrating medical device compliance with relevant...
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Regulatory Affairs Manager
vor 4 Wochen
Heidenheim an der Brenz, Baden-Württemberg, Deutschland PAUL HARTMANN AG VollzeitJoin Our Team as a Manager Regulatory Affairs ClinicalWe are seeking a highly skilled and experienced Manager Regulatory Affairs Clinical to join our global team at PAUL HARTMANN AG. As a key member of our regulatory affairs team, you will play a crucial role in ensuring the proper execution of procedures demonstrating medical device compliance with relevant...
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Regulatory Affairs Manager
vor 3 Wochen
Heidenheim an der Brenz, Baden-Württemberg, Deutschland PAUL HARTMANN AG VollzeitJoin Our Team as a Regulatory Affairs ManagerWe are seeking a highly skilled Regulatory Affairs Manager to support our global team in ensuring the proper execution of procedures demonstrating medical device compliance with relevant clinical performance and safety requirements.Key Responsibilities:Coordinate external service providers to support clinical...
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Regulatory Affairs Manager
vor 3 Wochen
Heidenheim an der Brenz, Baden-Württemberg, Deutschland PAUL HARTMANN AG VollzeitJoin Our Team as a Regulatory Affairs ManagerWe are seeking a highly skilled Regulatory Affairs Manager to support our global team in ensuring the proper execution of procedures demonstrating medical device compliance with relevant clinical performance and safety requirements.Key Responsibilities:Coordinate external service providers to support clinical...
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Regulatory Affairs Specialist
vor 3 Wochen
Giengen an der Brenz, Baden-Württemberg, Deutschland HARTMANN VollzeitStellenbeschreibungWir suchen einen motivierten und engagierten Werkstudenten (w/m/d) für unser Regulatory Affairs Team. Als Teil unseres Teams wirst du die Sicherheit und Leistungsfähigkeit von Medizinprodukten über den gesamten Produktlebenszyklus sicherstellen.AufgabenUnterstützung des Teams in administrativen und organisatorischen...
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Regulatory Affairs Specialist
vor 3 Wochen
Giengen an der Brenz, Baden-Württemberg, Deutschland HARTMANN VollzeitStellenbeschreibungWir suchen einen motivierten und engagierten Werkstudenten (w/m/d) für unser Regulatory Affairs Team. Als Teil unseres Teams wirst du die Sicherheit und Leistungsfähigkeit von Medizinprodukten über den gesamten Produktlebenszyklus sicherstellen.AufgabenUnterstützung des Teams in administrativen und organisatorischen...
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Medical Manager
vor 12 Stunden
Heidenheim an der Brenz, Baden-Württemberg, Deutschland PAUL HARTMANN AG VollzeitJoin Our Team as a Manager Regulatory Affairs ClinicalWe are Hartmann AG, a global company offering healthcare solutions. As a Manager Regulatory Affairs Clinical you will be an integral part of our team, supporting healthcare professionals with our products and services.About the RoleWe are seeking an experienced professional with a strong background in...
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Werkstudent Regulatory Affairs
vor 2 Wochen
Giengen an der Brenz, Baden-Württemberg, Deutschland HARTMANN VollzeitWir suchen einen motivierten Werkstudenten (w/m/d) für unser Regulatory Affairs Team. Als Teil unseres Teams wirst du die Sicherheit und Leistungsfähigkeit von Medizinprodukten über den gesamten Produktlebenszyklus sicherstellen.Aufgaben:Unterstützung des Teams in administrativen und organisatorischen TätigkeitenVorbereitung der Erstellung der...
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Werkstudent Regulatory Affairs
vor 2 Wochen
Giengen an der Brenz, Baden-Württemberg, Deutschland HARTMANN VollzeitWir suchen einen motivierten Werkstudenten (w/m/d) für unser Regulatory Affairs Team. Als Teil unseres Teams wirst du die Sicherheit und Leistungsfähigkeit von Medizinprodukten über den gesamten Produktlebenszyklus sicherstellen.Aufgaben:Unterstützung des Teams in administrativen und organisatorischen TätigkeitenVorbereitung der Erstellung der...
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Regulatory Affairs Specialist
vor 2 Wochen
Giengen an der Brenz, Baden-Württemberg, Deutschland HARTMANN VollzeitWir suchen nach einer Persönlichkeit, die sich für die Zulassung von Medizinprodukten begeistert und Teil unseres Teams wird, das die Sicherheit und Leistungsfähigkeit über den gesamten Produktlebenszyklus sicherstellt. Unterstütze unser Regulatory Affairs Team als Werkstudent (w/m/d) und lerne die entscheidenden Aspekte der Zulassung...
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Head of Regulatory Affairs Medical Devices
vor 4 Wochen
Heidenheim an der Brenz, Baden-Württemberg, Deutschland PAUL HARTMANN AG VollzeitJob Title: Head of Regulatory Affairs Medical DevicesAt PAUL HARTMANN AG, we're committed to helping healthcare professionals deliver exceptional care. As the Head of Regulatory Affairs Medical Devices, you'll play a crucial role in ensuring our medical devices meet the highest regulatory standards.Responsibilities:Develop and implement regulatory strategies...
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Head of Regulatory Affairs Medical Devices
vor 4 Wochen
Heidenheim an der Brenz, Baden-Württemberg, Deutschland PAUL HARTMANN AG VollzeitJob Title: Head of Regulatory Affairs Medical DevicesAt PAUL HARTMANN AG, we're committed to helping healthcare professionals deliver exceptional care. As the Head of Regulatory Affairs Medical Devices, you'll play a crucial role in ensuring our medical devices meet the highest regulatory standards.Responsibilities:Develop and implement regulatory strategies...
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Regulatory Affairs Manager for Clinical Evaluation
vor 4 Wochen
Heidenheim an der Brenz, Baden-Württemberg, Deutschland PAUL HARTMANN AG VollzeitJob Title: Regulatory Affairs Manager for Clinical EvaluationAt PAUL HARTMANN AG, we're committed to helping healthcare professionals deliver exceptional care. As a Regulatory Affairs Manager for Clinical Evaluation, you'll play a crucial role in ensuring our medical devices meet the highest standards of safety and performance.Key Responsibilities:Provide...
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Regulatory Affairs Manager for Clinical Evaluation
vor 4 Wochen
Heidenheim an der Brenz, Baden-Württemberg, Deutschland PAUL HARTMANN AG VollzeitJob Title: Regulatory Affairs Manager for Clinical EvaluationAt PAUL HARTMANN AG, we're committed to helping healthcare professionals deliver exceptional care. As a Regulatory Affairs Manager for Clinical Evaluation, you'll play a crucial role in ensuring our medical devices meet the highest standards of safety and performance.Key Responsibilities:Provide...
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Regulatory Affairs Spezialist
vor 4 Wochen
Biberach an der Riß, Baden-Württemberg, Deutschland Randstad Deutschland VollzeitRegulatory Affairs AssociateWir suchen einen motivierten und engagierten Regulatory Affairs Associate, der sich für die Zulassung von Arzneimitteln und Medizinprodukten begeistert. Als Teil unseres Teams werden Sie an der Koordination und Überwachung aller Aktivitäten zur Erlangung und Aufrechterhaltung von Produktzulassungen...
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Regulatory Affairs Spezialist
vor 4 Wochen
Biberach an der Riß, Baden-Württemberg, Deutschland Randstad Deutschland VollzeitRegulatory Affairs AssociateWir suchen einen motivierten und engagierten Regulatory Affairs Associate, der sich für die Zulassung von Arzneimitteln und Medizinprodukten begeistert. Als Teil unseres Teams werden Sie an der Koordination und Überwachung aller Aktivitäten zur Erlangung und Aufrechterhaltung von Produktzulassungen...
Regulatory Affairs Executive
vor 2 Monaten
About PAUL HARTMANN AG:
At PAUL HARTMANN AG, our mission is to support, protect, and enhance the healthcare experience. We empower healthcare professionals to focus on their vital work of improving lives. Our innovative solutions are designed to make a significant impact, and your dedication can foster personal growth in your career.
Position Overview:
As the Head of Regulatory Affairs within our Risk Prevention division, you will hold a pivotal role on the Divisional Management Board, overseeing all regulatory obligations associated with our diverse product range. This includes medical devices, system and procedure packs, personal protective equipment, and various commodities. You will also be instrumental in shaping our regulatory strategy and leading the regulatory affairs team.
Key Responsibilities:
- Ensure adherence to all regulatory standards for the complete product portfolio across relevant markets, including the oversight of specified standards and legal requirements.
- Assist the business division in formulating and executing regulatory strategies aligned with project goals and strategic initiatives.
- Lead the Regulatory Affairs department, managing a team of six professionals.
- Assess and establish the appropriate regulatory strategy for each product.
- Oversee, coordinate, and contribute to post-market surveillance, labeling, regulatory documentation, and conformity assessments for the division.
- Participate in drafting and reviewing regulatory processes, ensuring that resources and activities align with commercial objectives.
- Contribute to clinical, biological, risk management, usability, and standards & regulations management for the division.
Qualifications:
- A university degree in life sciences, natural sciences, or a related field.
- A minimum of five years of relevant experience in a Regulatory Affairs role within an international organization.
- Qualification as PRRC in accordance with MDR.
- In-depth knowledge of regulatory requirements for medical devices (e.g., MDR, MDD, MPG/MPDG/MPSV, MEDDEV, EN ISO 13485, 21 CFR 820), personal protective equipment, and in-vitro diagnostics concerning product safety and risk management.
- Demonstrated experience in leading and developing teams.
- Strong project management capabilities, particularly in managing international projects.
- Excellent communication and collaboration skills, with a proven ability to work effectively with cross-functional stakeholders at all levels, including in a matrix organization.
- Fluency in written and spoken English and German.
Benefits:
- Flexible working arrangements, including adaptable hours and remote work options.
- International mobile working opportunities.
- Supportive measures for balancing work and family life, such as childcare subsidies.
- Company vehicle with private usage included.
- 30 days of paid leave annually, plus additional leave for significant life events.
- Company pension plan with attractive employer contributions, including a matching model for deferred compensation.
- Ample parking, a canteen with a café bar, and ongoing employee shop offers.
- Access to over 6000 fitness and wellness facilities, including swimming pools and specialized fitness centers.
- A variety of health and wellness initiatives, such as skin cancer screenings, online mental health courses, and lunchtime yoga sessions.
- Job bike leasing options.
- Exclusive discounts on travel, fashion, and technology through our corporate benefits platform.
Join us in shaping a career dedicated to healthcare customers, designed for the future, and rooted in a culture of trust and transparency.