Clinical Compliance Specialist

Dentsply Sirona

Dentsply Sirona

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Key information

  • Publication date:

    22 February 2024
  • Workload:

    100%
  • Contract type:

    Permanent position
  • Language:

    English (Intermediate)
  • Place of work:

    Ballaigues

In this role you will be performing Clinical Evaluations, Systematic Literature Searches, and planning and reporting of continuous Post-Market Clinical Follow-up (PMCF).
The responsibilities start during the product development process and apply for the Dentsply Sirona medical device portfolio – with focus on endodontic products – throughout each product’s entire life cycle.
When performing Clinical Evaluations and PMCF the Clinical Compliance Specialist follows the applicable laws, guidelines, and internal processes.

Key Responsibilities:

Clinical Evaluations

  • Performing clinical evaluations according to applicable Medical Device regulations / guidelines for new developed products and updating the documentation throughout the entire life cycle of assigned parts of the Dentsply Sirona product portfolio
  • Compiling Clinical Evaluation Plans (CEP) and Clinical Evaluation Reports (CER)
  • Planning, performing and documenting systematic literature searches
  • Support the review / approval process in the electronic system.

Post-Market Clinical Follow-up (PMCF)

  • Compiling PMCF plans and communicating the plans in accordance with applicable Medical Device regulations / guidelines
  • Following up/ performing the PMCF activities
  • Compiling PMCF reports
  • Coordinating timelines and contents with stakeholders / activity owners

Miscellaneous

  • Providing Clinical Evaluation and PMCF input to other processes such as Post-Market Surveillance, Summary of Safety and Clinical Performance, Clinical Development Planning etc.
  • Supporting the Clinical Compliance respondent in audits
  • Support the global Clinical Compliance Team according to the overall priorities

Requirements and Qualification:

You hold at least a Master’s Degree in Life Sciences, Bioengineering, dentistry or a related subject. A PhD or doctoral degree would be a plus.
You have a minimum of 1 year working experience in the field of Clinical Evaluations, Medical Writing or Clinical Research within the medical device sector, preferably related to dental medical devices and/or dental health.
Previously you gained knowledge in systematic scientific literature searches, Clinical Research (Clinical Investigations), regulatory writing and / or dentistry and the medical device regulations (e. g. MDR, FDA regulations), applicable standards (e. g. ISO 14155) and guidance (e. g. MDCGs, MEDDEV 2.7/1) are not new to you.
You have a basic understanding of statistics and MS Office and databases. Your English language (verbally and written) are very well developed (at least C1 level).

At Dentsply Sirona we offer a market conform salary, very attractive benefits, and an informal working environment. We are a diverse workforce and are passionate about the work we do!

Contact

  • Femke Kok Courant
  • Dentsply Sirona

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