Manager PMS

Vor 3 Tagen

Basel, Schweiz CAMLOG Biotechnologies GmbH Vollzeit
Manager PMS / Clinical Evaluations (m/w/d)

To further strengthen our team in Basel, Switzerland, we have an immediate opening for a

Manager PMS / Clinical Evaluations (m/w/d)

Your Prospects:

International employer with team-oriented working atmosphere

Intensive training in all relevant areas of the company

Modern work equipment and various amenities such as free fruit, water, coffee and tea

Attractive employment conditions

Individual further training opportunities

Your Tasks:

  • Drive the compilation of Clinical Evaluation Plans and Reports according to the requirements of the MDR and MEDDEV 2.7/1 Revision 4
  • Take responsibility for setting up PMS & PMCF plans according to the requirements of European regulations for medical devices
  • Actively support project teams during the development of new products and provide consultancy regarding the Clinical Evaluation strategy and requirements for PMCF
  • Compile and update PSURs / PMS & PMCF reports in a timely manner
  • Ensure that sufficient pertinent clinical data for all medical devices of the Camlog product range are available
  • Systematically update the collection of pertinent clinical data, which includes (inter alia):
    - periodic systematic literature search
    - update of sales & complaint statistics
    - evaluation of sales reports regarding customer feedback on own & competitor products
    - evaluation of data from competent authorities on reportable events (own and competitors’ products)
  • Support the RA team in respect to Clinical Evaluations and PMS activities in international markets
  • Provide support to the implementation and documentation of change requests and extension projects, ensuring the integration in existing CEP, CER & PMS / PMCF documentations
  • Close cooperation with Regulatory Affairs, Brand Management, and Product Development

Your Profile:

  • Master's degree in technical or medical sciences and engineering or relevant industry experience; Ph.D. is an advantage
  • Completed professional formation plus a minimum of 5 years of work experience in the medical device industry or in a related field
  • Ideally 1-3 years of experience in PMS / PMCF, clinical evaluation writing, or in the regulatory affairs environment
  • Knowledge of regulatory requirements for medical devices (MDR), in particular requirements regarding PMS / PMCF and writing clinical evaluations
  • Experience in quality management, product development, testing, and manufacturing of medical devices is a plus
  • Excellent interpersonal skills, with the ability to collaborate effectively with internal and external stakeholders
  • Experience in the dental field is an advantage
  • Experience in working in a multi-project environment / matrix organization
  • Excellent MS Office skills; experience with literature search in relevant databases; user knowledge of SAP is a plus
  • Excellent verbal and written language skills both in English and German are a must; skills in any additional language are an advantage

Are you looking for a new challenge in a successful company? At CAMLOG, we produce innovative products for implant dentistry. With the CAMLOG implant system, we are one of the market leaders in our industry. We owe this position not only to customers who value us as a reliable partner, but also to our highly motivated employees. They ensure the continuous technical and qualitative development of our products and processes.

#J-18808-Ljbffr

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