Regulatory Affairs Clinical Specialist

Vor 2 Tagen

Heidenheim, Deutschland PAUL HARTMANN AG - Karriere Vollzeit

Discover a rewarding career opportunity at PAUL HARTMANN AG - Karriere as a Regulatory Affairs Clinical Specialist. With a focus on medical device compliance, you will play a crucial role in ensuring the proper execution of procedures.

About Us:

We are a global team that offers a varied and challenging position in an international environment. As a key member of our Regulatory Affairs team, you will have the opportunity to develop your skills and contribute to the success of our company.

About the Job:

This is a fantastic chance to join our team as a Clinical Evaluation Manager. As part of our Regulatory Affairs department, you will be responsible for providing and updating documentation of clinical evaluation, post-market clinical follow-up and post-marketing surveillance.

Your Key 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 accordance with MDR/MEDDEV 2.7.1 rev. 4
  • Provide searches in relevant vigilance databases
  • Support risk analysis and study planning for CE and PMCF studies

About You:

  • 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

Salary and Benefits:

The estimated annual salary for this position is €65,000-€80,000 depending on qualifications and location. We also offer attractive benefits including flexible working conditions, international mobile working, childcare subsidy, 30 days paid leave per year, plus special leave for exceptional life events, vacation pay, 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, 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, job bike leasing, and attractive discounts on e.g. travel, fashion and technology via our corporate benefits platform.

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