• Job Description

  Req#: 76200

  Requistion ID: 76200

  Dentsply Sirona is the world’s largest manufacturer of professional dental products and technologies, with a 130-year history of innovation and service to the dental industry and patients worldwide. Dentsply Sirona develops, manufactures, and markets a comprehensive solutions offering including dental and oral health products as well as other consumable medical devices under a strong portfolio of world class brands. Dentsply Sirona’s products provide innovative, high-quality and effective solutions to advance patient care and deliver better and safer dentistry. Dentsply Sirona’s global headquarters is located in Charlotte, North Carolina, USA. The company’s shares are listed in the United States on NASDAQ under the symbol XRAY. Bringing out the best in people As advanced as dentistry is today, we are dedicated to making it even better. Our people have a passion for innovation and are committed to applying it to improve dental care. We live and breathe high performance, working as one global team, bringing out the best in each other for the benefit of dental patients, and the professionals who serve them. If you want to grow and develop as a part of a team that is shaping an industry, then we’re looking for the best to join us. Working at Dentsply Sirona you are able to: Develop faster - with our commitment to the best professional development. Perform better - as part of a high-performance, empowering culture. Shape an industry - with a market leader that continues to drive innovation. Make a difference -by helping improve oral health worldwide.

  You are an analytical supporter and like the balance between collaboration with others and independent work?
  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.

  Clinical Compliance Specialist - Ballaigues, Switzerland
  

  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!

• About the company

  Dentsply Sirona is an American dental equipment manufacturer and dental consumables producer that markets its products in over 120 countries.

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