Clinical Assessment Lead

vor 4 Wochen

Heidenheim an der Brenz, Baden-Württemberg, Deutschland PAUL HARTMANN AG Vollzeit
Join Our Team as a Clinical Evaluation Manager

At 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 international setting.

Key Responsibilities:
  • Develop and maintain documentation for clinical evaluations, post-market clinical follow-ups, and post-marketing surveillance.
  • Facilitate cross-departmental communication with teams such as Marketing and Research & Development to ensure documentation is current and comprehensive.
  • Coordinate with external service providers to assist in clinical evaluation documentation, PMCF, and PMS activities.
  • Identify clinical evidence requirements in compliance with MDR and relevant MDCGs.
  • Conduct literature searches and reviews in accordance with MDR/MEDDEV 2.7.1 rev. 4.
  • Perform searches in relevant vigilance databases and support risk analysis and study planning for CE and PMCF studies.

Qualifications:
  • A university degree in life sciences, natural sciences, or a related field.
  • Professional experience in the medical device sector or a similar regulatory environment.
  • Strong knowledge of regulatory requirements, including MDR and relevant MDCGs.
  • Experience in literature search and review, along with regulatory medical writing skills.
  • Proficiency in database management and a collaborative approach to stakeholder engagement.
  • IT proficiency, particularly with the MS Office suite, and fluent in written and spoken English.

Benefits:
  • Flexible working arrangements, including adaptable hours and remote work options.
  • Support for work-life balance, including childcare subsidies.
  • Generous leave policies, including 30 days of paid vacation per year.
  • Company pension plan with attractive employer contributions.
  • Access to fitness and wellness programs, including discounts on various health services.
  • Opportunities for professional development in a culture of trust and openness.

Become part of a team that is committed to improving healthcare solutions. We look forward to welcoming you

  • 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...

  • 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 Trial Supply Chain Manager

    vor 4 Wochen

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

    Embrace a new opportunity as a Clinical Trial Supply Chain Manager with GULP – experts united. We are looking for a dedicated professional to oversee critical supply chain operations for Investigational Medicinal Products (IMPs) within national and international clinical trials. What We Offer Permanent employment opportunities with our esteemed...

  • Clinical Trial Supply Chain Manager

    vor 4 Wochen

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

    Opportunity for Growth Are you an experienced CTSU Trial Manager seeking a new opportunity? We have an exciting position available with GULP – experts united, a reputable pharmaceutical organization. This role offers a secure employment opportunity with competitive compensation and engaging responsibilities. What We Provide Potential for...

  • Chief of Regulatory Compliance and Risk Assessment

    vor 4 Wochen

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

    About PAUL HARTMANN AG:At PAUL HARTMANN AG, our mission is to support, protect, and enhance the quality of life for individuals through innovative healthcare solutions. We empower healthcare professionals to focus on what truly matters: making a positive impact on people's lives. Your dedication can lead to personal and professional growth every day.Position...

  • Chief of Regulatory Compliance and Risk Assessment

    Vor 4 Tagen

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

    About PAUL HARTMANN AG:At PAUL HARTMANN AG, our mission is to support, protect, and enhance the quality of life for individuals through innovative healthcare solutions. We empower healthcare professionals to focus on what truly matters: making a positive impact on people's lives. Your dedication can lead to personal and professional growth every day.Position...

  • Chief of Regulatory Affairs and Risk Assessment

    vor 4 Wochen

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

    About PAUL HARTMANN AG:At PAUL HARTMANN AG, our mission is to support, protect, and enhance the lives of healthcare professionals and their patients. We are dedicated to creating solutions that truly make a difference in the healthcare sector. Your dedication and expertise can help us grow and innovate every day.Position Overview:We are seeking a Head of...

  • Chief of Regulatory Affairs and Risk Assessment

    Vor 4 Tagen

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

    About PAUL HARTMANN AG:At PAUL HARTMANN AG, our mission is to support, protect, and enhance the lives of healthcare professionals and their patients. We are dedicated to creating solutions that truly make a difference in the healthcare sector. Your dedication and expertise can help us grow and innovate every day.Position Overview:We are seeking a Head of...

  • 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...

  • 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...

  • Senior Risk Management Leader

    vor 4 Wochen

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

    About Us:At PAUL HARTMANN AG, we empower healthcare professionals to concentrate on what truly matters: making a positive difference in people's lives.Position Overview:We are seeking a Head of Regulatory Affairs within our Risk Prevention division. As a key member of the Divisional Management Board, you will oversee all regulatory obligations associated...

  • Clinical Trial Supply Chain Manager

    vor 4 Wochen

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

    Embrace a New Opportunity Are you an experienced CTSU Trial Manager seeking a fresh challenge in your career? Look no further. We present an exciting opportunity with GULP – experts united, a prominent player in the pharmaceutical sector. What We Offer Potential for permanent employment with our esteemed partner Comprehensive social...

  • Clinical Trial Supply Chain Manager

    vor 4 Wochen

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

    Embrace a New Opportunity Are you an experienced CTSU Trial Manager seeking a fresh professional journey? We present an exciting opportunity within a prominent pharmaceutical organization. This role offers a stable position, competitive remuneration, and engaging responsibilities. What We Provide Potential for permanent employment with our...

  • Clinical Trial Supply Chain Manager

    vor 4 Wochen

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

    Embrace a New Opportunity Are you an experienced CTSU Trial Manager seeking a fresh professional challenge? Look no further. We present an exciting opportunity within a reputable pharmaceutical organization. What We Offer Potential for permanent employment with our esteemed partner Comprehensive social benefits, including holiday and Christmas...

  • Lead Development Support Specialist

    vor 4 Wochen

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

    Role Overview:As a key player in our team, you will facilitate healthcare professionals in their mission to enhance lives. Your role will serve as a vital link between external service providers, such as suppliers and manufacturers, and our internal teams, including procurement, focusing on wound therapy expertise.Key Responsibilities:Drive the development...

  • 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...

  • Lead Regulatory Affairs Specialist

    vor 4 Wochen

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

    At PAUL HARTMANN AG, our mission is to support , care for , protect , and enhance the well-being of individuals. We empower healthcare professionals to concentrate on what truly matters: making a positive impact on people's lives. Our solutions are designed to create meaningful change, and with your dedication, you can advance in your career every day....

  • Compliance and Risk Prevention Lead

    Vor 6 Tagen

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

    Job SummaryWe are seeking a highly experienced and skilled professional to lead our Regulatory Affairs team and drive the development of our regulatory strategy. As the Head of Regulatory Affairs and Risk Management, you will be responsible for ensuring compliance with all regulatory requirements for our medical device portfolio, including monitoring of...

  • Compliance and Risk Prevention Lead

    Vor 4 Tagen

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

    Job SummaryWe are seeking a highly experienced and skilled professional to lead our Regulatory Affairs team and drive the development of our regulatory strategy. As the Head of Regulatory Affairs and Risk Management, you will be responsible for ensuring compliance with all regulatory requirements for our medical device portfolio, including monitoring of...