Clinical Evaluation Manager

vor 5 Monaten

Heidenheim, Deutschland PAUL HARTMANN AG Vollzeit

At HARTMANN, we’re all in to help, care, protect and grow. We support healthcare professionals, that they can focus on what really matters: to positively impact people ́s life. We realize solutions that make a difference. And with your commitment you can grow on your job every day. At HARTMANN we believe in the difference you can make.

Join our team as

DEU-Heidenheim

At HARTMANN, you have the opportunity to become part of a global team. As a Manager Regulatory Affairs Clinical (f/m/d), we offer you a varied and challenging position in an international environment. Here, you can develop your skills and play an active role in ensuring the proper execution of procedures demonstrating medical device compliance with relevant clinical performance and safety requirements. If you are also enthusiastic about our meaningful product portfolio, we should get to know each other.

Responsibilities:

  • Provide and update documentation of clinical evaluation, post-market clinical follow-up and post-marketing surveillance
  • Cross-functional communication with other departments such as Marketing and R&D to ensure required input documentation is up to date
  • Coordinate external service providers to support clinical evaluation documentation, PMCF and PMS
  • Determine clinical evidence requirements according to MDR and relevant MDCGs
  • Identify equivalence to existing devices, if required, in accordance with MDRs and relevant MDCGs.
  • Conduct literature searches and reviews in according to MDR/MEDDEV 2.7.1 rev. 4
  • Provide searches in relevant vigilance databases
  • Support for risk analysis and study planning for CE and PMCF studies

Qualification:

  • University degree in life science/natural science or an equivalent qualification
  • Professional experience in the medical device environment or another regulatory field of work
  • Knowledge in regulatory requirements, MDR and relevant MDCGs, rel. MEDDEVs
  • Experience in literature search and review required as well as knowledge of regulatory medical writing
  • Knowledge of database management
  • Open and competent attitude when working with your stakeholders
  • IT affinity and proficiency with the MS Office package
  • Fluent written and spoken English

Benefits:

  • Flexible working conditions, such as flexible working hours and mobile working
  • International Mobile Working
  • Attractive ways of combining work and family life, e.g. childcare subsidy
  • 30 days paid leave per year, plus special leave for exceptional life events as well as vacation pay and special annual payment according to collective agreement
  • Company pension plan with attractive employer contribution incl. matching model for deferred compensation
  • Plenty of parking spaces, canteen with café bar and ongoing offers in the employee shop
  • Access to over 6000 fitness and yoga studios, swimming pools as well as Crossfit and bouldering halls (EGYM Wellpass)
  • Various health and fitness offers, e.g. skin cancer screenings, online courses for mental health, massage offers, yoga during lunch break etc.
  • Job Bike Leasing
  • Attractive discounts on e.g. travel, fashion and technology via our corporate benefits platform

Shape a career that’s focused on healthcare customers, fit for the future and grounded in a culture of trust and openness. Apply now via our online platform.

Your personal contact:

​Isabel Proske

#hartmann

  • Clinical Evaluation Manager

    vor 5 Monaten

    Heidenheim, Deutschland PAUL HARTMANN AG Vollzeit

    At HARTMANN, we’re all in to help , care , protect and grow . We support healthcare professionals, that they can focus on what really matters: to positively impact people´s life. We realize solutions that make a difference. And with your commitment you can grow on your job every day. At HARTMANN we believe in the difference you can make. Join...

  • Clinical Evaluation Manager

    vor 5 Monaten

    Heidenheim, Deutschland PAUL HARTMANN AG Vollzeit

    At HARTMANN, we’re all in to help, care, protect and grow. We support healthcare professionals, that they can focus on what really matters: to positively impact people´s life. We realize solutions that make a difference. And with your commitment you can grow on your job every day. At HARTMANN we believe in the difference you can make. Join our team as ...

  • Clinical Evaluation Manager

    vor 5 Monaten

    Heidenheim, Deutschland PAUL HARTMANN AG - Karriere Vollzeit

    At HARTMANN, we’re all in to help, care, protect and grow. We support healthcare professionals, that they can focus on what really matters: to positively impact people´s life. We realize solutions that make a difference. And with your commitment you can grow on your job every day. At HARTMANN we believe in the difference you can make. Join our team as ...

  • Clinical Evaluation Manager

    vor 5 Monaten

    Heidenheim, 89522, Heidenheim an der Brenz, Deutschland PAUL HARTMANN AG Vollzeit

    At HARTMANN, we’re all in to help, care, protect and grow. We support healthcare professionals, that they can focus on what really matters: to positively impact people´s life. We realize solutions that make a difference. And with your commitment you can grow on your job every day. At HARTMANN we believe in the difference you can make. Join our team as ...

  • Regulatory Affairs Manager for Clinical Evaluation

    vor 4 Wochen

    Heidenheim, Deutschland PAUL HARTMANN AG Vollzeit

    At HARTMANN, we’re all in to help , care , protect and grow . We support healthcare professionals, that they can focus on what really matters: to positively impact people´s life. We realize solutions that make a difference. And with your commitment you can grow on your job every day. At HARTMANN we believe in the difference you...

  • Regulatory Affairs Clinical Manager

    vor 4 Wochen

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

    Transforming Healthcare through Regulatory ExcellenceAt PAUL HARTMANN AG, we're committed to helping healthcare professionals deliver the best possible care. As a Clinical Research Manager for Regulatory Affairs, you'll play a vital role in ensuring the proper execution of clinical procedures, guaranteeing medical device compliance with relevant performance...

  • Medical Manager

    vor 4 Wochen

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

    Join 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...

  • Global Medical Director

    vor 5 Monaten

    Heidenheim, Deutschland PAUL HARTMANN AG - Karriere Vollzeit

    We support healthcare professionals, that they can focus on what really matters: to positively impact people´s life. span> Join our team as DEU-Heidenheim At HARTMANN, you have the opportunity to become part of a global team. As a Manager Regulatory Affairs Clinical (f/m/d), we offer you a varied and challenging position in an international...

  • Toxicology and Biological Evaluation Expert

    vor 4 Wochen

    Heidenheim, Deutschland PAUL HARTMANN AG Vollzeit

    Responsibilities: Interpret ISO 10993 requirements and evaluate outcomes considering device factors, intended use, and scientific knowledge Create biological evaluation plans/reports and coordinate biological testing with external labs and Toxicologists Support the development of biological strategy Assistance to...

  • Specialist Biological Evaluation

    vor 2 Monaten

    Heidenheim, Deutschland PAUL HARTMANN AG Vollzeit

    Responsibilities: Interpret ISO 10993 requirements and evaluate outcomes considering device factors, intended use, and scientific knowledge Create biological evaluation plans/reports and coordinate biological testing with external labs and Toxicologists Support the development of biological strategy Assistance to representatives of the Business Division and...

  • Medical Manager

    vor 5 Monaten

    Heidenheim, Deutschland PAUL HARTMANN AG Vollzeit

    We support healthcare professionals, that they can focus on what really matters: to positively impact people´s life. At HARTMANN, you have the opportunity to become part of a global team. As a Manager Regulatory Affairs Clinical (f/m/d), we offer you a varied and challenging position in an international environment. Here, you can develop your skills and...

  • Medical Specialist

    vor 2 Monaten

    Heidenheim, Deutschland PAUL HARTMANN AG - Karriere Vollzeit

    Responsibilities: Interpret ISO 10993 requirements and evaluate outcomes considering device factors, intended use, and scientific knowledge Create biological evaluation plans/reports and coordinate biological testing with external labs and Toxicologists Support the development of biological strategy Assistance to representatives of the Business Division and...

  • Biological Safety Engineer

    vor 1 Monat

    Heidenheim, Deutschland PAUL HARTMANN AG Vollzeit

    Responsibilities: Interpret ISO 10993 requirements and evaluate outcomes considering device factors, intended use, and scientific knowledge Create biological evaluation plans/reports and coordinate biological testing with external labs and Toxicologists Support the development of biological strategy Assistance to representatives of the Business Division and...

  • Medical Device Compliance Specialist

    vor 2 Wochen

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

    Job DescriptionWe support healthcare professionals to positively impact people's lives. At HARTMANN, you have the opportunity to become part of a global team as a Manager Regulatory Affairs Clinical (f/m/d). This role offers a challenging position in an international environment where you can develop your skills and contribute to ensuring medical device...

  • Regulatory Affairs Expert

    vor 3 Wochen

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

    We are seeking a highly skilled Regulatory Affairs Manager to join our global team at PAUL HARTMANN AG. In this role, you will play a crucial part in ensuring the proper execution of procedures demonstrating medical device compliance with relevant clinical performance and safety requirements.Key responsibilities will include:External Service Coordination:...

  • Biocompatibility Specialist

    vor 2 Monaten

    Landkreis Heidenheim, Deutschland PAUL HARTMANN AG Vollzeit

    Responsibilities: Interpret ISO 10993 requirements and evaluate outcomes considering device factors, intended use, and scientific knowledge Create biological evaluation plans/reports and coordinate biological testing with external labs and Toxicologists Support the development of biological strategy Assistance to representatives of the Business...

  • Biological Safety Engineer

    vor 2 Monaten

    Heidenheim, 89522, Heidenheim an der Brenz, Deutschland PAUL HARTMANN AG Vollzeit

    Responsibilities: Interpret ISO 10993 requirements and evaluate outcomes considering device factors, intended use, and scientific knowledge Create biological evaluation plans/reports and coordinate biological testing with external labs and Toxicologists Support the development of biological strategy Assistance to representatives of the Business Division and...

  • Manager (m/w/d) Product Development

    vor 2 Monaten

    Heidenheim, Deutschland PAUL HARTMANN AG Vollzeit

    h3> Idea generation for new products and technologies with a focus on electrical engineering Development of new products in compliance with relevant regulations and standards Assist in technical design questions and support project management activities Set up electrical testing setups and collaborate with suppliers Technical responsibility for a dedicated...

  • Manager Global Product Development

    vor 4 Wochen

    Heidenheim, Deutschland PAUL HARTMANN AG Vollzeit

    Responsibilities: Idea generation for new products and technologies with a focus on electrical engineering Development of new products in compliance with relevant regulations and standards Assist in technical design questions and support project management activities Set up electrical testing setups and collaborate with...

  • Manager Global Product Development

    vor 2 Monaten

    Heidenheim, Deutschland PAUL HARTMANN AG Vollzeit

    Responsibilities: Idea generation for new products and technologies with a focus on electrical engineering Development of new products in compliance with relevant regulations and standards Assist in technical design questions and support project management activities Set up electrical testing setups and collaborate with suppliers Technical responsibility for...