Manager of Clinical Evaluations

vor 4 Wochen

Heidenheim an der Brenz, Baden-Württemberg, Deutschland PAUL HARTMANN AG Vollzeit

About PAUL HARTMANN AG: At PAUL HARTMANN AG, we are dedicated to enhancing healthcare outcomes. Our mission is to empower healthcare professionals, enabling them to focus on what truly matters: improving lives. We develop innovative solutions that create a significant impact. With your dedication, you can advance your career every day.

Position Overview: We invite you to join our dynamic team as a Clinical Evaluation Manager. In this pivotal role, you will have the chance to contribute to a global initiative. This position offers a diverse and stimulating environment where you can refine your expertise and actively participate in ensuring compliance with clinical performance and safety standards for medical devices.

Key Responsibilities:

  • Maintain and enhance documentation related to clinical evaluations, post-market clinical follow-ups, and post-marketing surveillance.
  • Facilitate cross-departmental communication with teams such as Marketing and R&D to ensure all necessary documentation is current.
  • Oversee external service providers to assist with clinical evaluation documentation, PMCF, and PMS.
  • Establish clinical evidence requirements in accordance with MDR and relevant MDCGs.
  • Assess equivalence to existing devices when necessary, following MDRs and applicable MDCGs.
  • Conduct comprehensive literature searches and reviews as per MDR/MEDDEV 2.7.1 rev. 4.
  • Perform searches in pertinent vigilance databases.
  • Support risk analysis and study planning for CE and PMCF studies.

Qualifications:

  • A degree in life sciences or natural sciences, or an equivalent qualification.
  • Experience in the medical device sector or a related regulatory field.
  • Familiarity with regulatory requirements, including MDR and relevant MDCGs, as well as MEDDEVs.
  • Proficient in literature search and review, with a solid understanding of regulatory medical writing.
  • Experience in database management.
  • A collaborative and professional approach when engaging with stakeholders.
  • Strong IT skills, particularly with the MS Office suite.
  • Fluency in written and spoken English.

What We Offer:

  • Flexible working arrangements, including adaptable hours and remote work options.
  • International mobility opportunities.
  • Supportive policies for balancing work and family life, such as childcare subsidies.
  • Generous paid leave, including special leave for significant life events, along with vacation pay and annual bonuses.
  • A company pension plan with competitive employer contributions, including a matching model for deferred compensation.
  • Ample parking, an on-site canteen with a café bar, and ongoing employee shop offers.
  • Access to a wide range of fitness and wellness facilities, including over 6000 fitness centers and health programs.
  • Job Bike Leasing and attractive discounts on travel, fashion, and technology through our corporate benefits platform.

Join us in shaping a career that prioritizes healthcare customers, is future-ready, and rooted in a culture of trust and transparency.

  • Clinical Evaluation Specialist

    vor 4 Wochen

    Heidenheim an der Brenz, Baden-Württemberg, Deutschland PAUL HARTMANN AG Vollzeit

    Join Our Team as a Clinical Evaluation ManagerAt PAUL HARTMANN AG, we are dedicated to enhancing healthcare outcomes and supporting professionals in their mission to improve lives. We invite you to be part of our global team, where your contributions will help shape the future of healthcare.Position Overview:As a Clinical Evaluation Manager, you will play a...

  • Clinical Evaluation Manager

    vor 4 Wochen

    Heidenheim an der Brenz, Baden-Württemberg, Deutschland PAUL HARTMANN AG Vollzeit

    Join Our Team as a Medical ManagerAt PAUL HARTMANN AG, we empower healthcare professionals to concentrate on what truly matters: making a positive difference in people's lives. As a Medical Manager, you will have the chance to be part of a global team, taking on a diverse and stimulating role within an international setting.Your Responsibilities:- Oversee...

  • Manager of Clinical Assessments

    vor 4 Wochen

    Heidenheim an der Brenz, Baden-Württemberg, Deutschland PAUL HARTMANN AG Vollzeit

    Join Our Team as a Clinical Evaluation ManagerAt PAUL HARTMANN AG, we are dedicated to enhancing healthcare outcomes through innovation and support. We empower healthcare professionals to focus on what truly matters: making a positive impact on patients' lives. Your commitment will enable you to grow and thrive in your role.Position Overview:As a Clinical...

  • Clinical Affairs Manager

    vor 4 Wochen

    Heidenheim an der Brenz, Baden-Württemberg, Deutschland PAUL HARTMANN AG Vollzeit

    Join Our Team as a Clinical Evaluation ManagerAt PAUL HARTMANN AG, we are dedicated to supporting healthcare professionals in their mission to enhance patient care. We believe in the power of your contributions to make a meaningful impact on lives. As a Clinical Evaluation Manager, you will be part of a dynamic global team, where your expertise will play a...

  • Clinical Compliance Manager

    vor 4 Wochen

    Heidenheim an der Brenz, Baden-Württemberg, Deutschland PAUL HARTMANN AG Vollzeit

    Join Our Team at PAUL HARTMANN AGAt PAUL HARTMANN AG, we are dedicated to enhancing healthcare through innovative solutions. We empower healthcare professionals to focus on what truly matters: making a positive impact on patients' lives. With your dedication, you can grow in your role every day. As a part of our global team, we invite you to explore the...

  • Clinical Regulatory Manager

    vor 3 Wochen

    Heidenheim an der Brenz, Baden-Württemberg, Deutschland PAUL HARTMANN AG Vollzeit

    Join PAUL HARTMANN AG and contribute to our mission of enhancing healthcare solutions. We are dedicated to supporting healthcare professionals in their vital work, ensuring they can focus on what truly matters: improving lives. Position Overview: As a Clinical Evaluation Manager, you will play a crucial role in our international team. This position offers a...

  • Clinical Assessment Manager

    vor 3 Wochen

    Heidenheim an der Brenz, Baden-Württemberg, Deutschland PAUL HARTMANN AG Vollzeit

    Join PAUL HARTMANN AG and contribute to our mission of enhancing healthcare. We are dedicated to supporting healthcare professionals, allowing them to focus on what truly matters: improving lives. With your dedication, you can advance in your career every day. Position Overview: As a Clinical Evaluation Manager, you will be part of a global team, engaging in...

  • Clinical Compliance Manager

    vor 3 Wochen

    Heidenheim an der Brenz, Baden-Württemberg, Deutschland PAUL HARTMANN AG Vollzeit

    Join Our Team at PAUL HARTMANN AG At PAUL HARTMANN AG, we are dedicated to supporting healthcare professionals in their mission to enhance patient care. Our commitment to innovation and quality drives us to develop solutions that truly make a difference in people's lives. Your Role As a Clinical Evaluation Manager, you will play a crucial role in our...

  • Clinical Compliance Manager

    vor 4 Wochen

    Heidenheim an der Brenz, Baden-Württemberg, Deutschland PAUL HARTMANN AG Vollzeit

    About Us: At PAUL HARTMANN AG, we are dedicated to supporting healthcare professionals in their mission to enhance the quality of life for individuals. Our commitment to innovation drives us to develop solutions that truly make a difference. Position Overview: We invite you to join our dynamic team as a Clinical Evaluation Manager. This role offers a unique...

  • Clinical Performance Manager

    vor 4 Wochen

    Heidenheim an der Brenz, Baden-Württemberg, Deutschland PAUL HARTMANN AG Vollzeit

    Join Our Team at PAUL HARTMANN AG At PAUL HARTMANN AG, we are dedicated to enhancing healthcare by supporting professionals in their mission to improve lives. We develop innovative solutions that truly make a difference. With your dedication, you can advance your career every day. Position Overview As a Clinical Evaluation Manager, you will be part of a...

  • Clinical Affairs Manager

    vor 4 Wochen

    Heidenheim an der Brenz, Baden-Württemberg, Deutschland PAUL HARTMANN AG Vollzeit

    Join Our Team as a Medical ManagerAt PAUL HARTMANN AG, we empower healthcare professionals to concentrate on what truly matters: making a positive difference in people's lives. As a Medical Manager, you will be an integral part of our global team, taking on a diverse and stimulating role within an international setting.Your Responsibilities:- Oversee the...

  • Clinical Assessment Lead

    vor 4 Wochen

    Heidenheim an der Brenz, Baden-Württemberg, Deutschland PAUL HARTMANN AG Vollzeit

    Join Our Team as a Clinical Evaluation ManagerAt PAUL HARTMANN AG, we are dedicated to enhancing healthcare outcomes through innovation and support. We empower healthcare professionals to focus on what truly matters: making a positive impact on patients' lives. With your expertise, you can thrive in a role that offers both challenge and growth in a dynamic...

  • Regulatory Affairs Manager

    vor 4 Wochen

    Heidenheim an der Brenz, Baden-Württemberg, Deutschland PAUL HARTMANN AG Vollzeit

    Position Overview:At PAUL HARTMANN AG, we empower healthcare professionals to concentrate on what truly matters: making a positive difference in people's lives. We are seeking a dedicated Manager of Regulatory Affairs Clinical to join our dynamic global team. This role presents a diverse and stimulating opportunity within an international setting.Key...

  • Healthcare Regulatory Manager

    vor 4 Wochen

    Heidenheim an der Brenz, Baden-Württemberg, Deutschland PAUL HARTMANN AG Vollzeit

    Join Our Team as a Medical ManagerAt PAUL HARTMANN AG, we empower healthcare professionals to concentrate on what truly matters: making a positive difference in people's lives. As a Medical Manager, you will be part of a dynamic global team and take on a diverse and stimulating role within an international setting.Your Responsibilities:- Oversee the...

  • Healthcare Compliance Manager

    vor 4 Wochen

    Heidenheim an der Brenz, Baden-Württemberg, Deutschland PAUL HARTMANN AG Vollzeit

    Position Overview:At PAUL HARTMANN AG, we empower healthcare professionals to concentrate on what truly matters: making a positive difference in people's lives. We are seeking a Manager of Regulatory Affairs Clinical (f/m/d) to join our dynamic global team. This role presents a diverse and stimulating opportunity within an international setting.Key...

  • Director of Global Medical Affairs

    vor 4 Wochen

    Heidenheim an der Brenz, Baden-Württemberg, Deutschland PAUL HARTMANN AG - Karriere Vollzeit

    About the Role:At PAUL HARTMANN AG, we empower healthcare professionals to concentrate on their core mission: enhancing the quality of life for individuals. As a Global Medical Director, you will play a pivotal role in our international operations, ensuring that our medical devices meet the highest standards of clinical performance and safety.Key...

  • Director of Global Medical Affairs

    vor 4 Wochen

    Heidenheim an der Brenz, Baden-Württemberg, Deutschland PAUL HARTMANN AG - Karriere Vollzeit

    Overview:At PAUL HARTMANN AG, we empower healthcare professionals to focus on their essential mission: enhancing the quality of life for individuals. We are currently seeking a qualified individual for the role of Global Medical Director.Position Summary:This role offers a diverse and stimulating opportunity within an international framework. You will play a...

  • Medical Device Regulatory Manager

    vor 4 Wochen

    Heidenheim an der Brenz, Baden-Württemberg, Deutschland PAUL HARTMANN AG Vollzeit

    Join Our Team as a Medical ManagerAt PAUL HARTMANN AG, we empower healthcare professionals to concentrate on what truly matters: making a positive difference in people's lives. As a Medical Manager, you will be part of a dynamic global team, taking on a diverse and stimulating role within an international context.Your Responsibilities:- Oversee and...

  • Clinical Trial Supply Chain Manager

    Vor 6 Tagen

    Biberach an der Riß, Baden-Württemberg, Deutschland GULP – experts united Vollzeit

    Job SummaryWe are seeking a highly skilled Clinical Trial Supply Chain Manager to join our team at GULP – experts united. As a key member of our organization, you will be responsible for ensuring the timely and cost-efficient provision of clinical supplies for national and international Phase I-IV clinical trials in the Therapeutic Area General...

  • Clinical Trial Supply Chain Manager

    Vor 3 Tagen

    Biberach an der Riß, Baden-Württemberg, Deutschland GULP – experts united Vollzeit

    Job SummaryWe are seeking a highly skilled Clinical Trial Supply Chain Manager to join our team at GULP – experts united. As a key member of our organization, you will be responsible for ensuring the timely and cost-efficient provision of clinical supplies for national and international Phase I-IV clinical trials in the Therapeutic Area General...