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 peopleAs 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.The Clinical Compliance Manager is responsible for the following scope:
Ensuring the performance of Clinical Evaluations and compiling Clinical Evaluation Reports (CER)
Ensuring the proper planning and reporting of continuous Post-Market Clinical Follow-up (PMCF)
Ensuring the conduct of Systematic Literature Searches
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 Manager follows the applicable laws, guidelines, and internal processes.The responsibilities of the Clinical Compliance Manager also include the management of consultants as well as the input / support for strategic planning of the document preparation.Clinical Compliance Manager - Ballaigues, SwitzerlandRole and Responsabilities: 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
Coordinate consultants as applicable
Coordinate the review / approval process in the electronic system
Support the strategic planning of the CERs
Post-Market Clinical Follow-up (PMCF)
Planning of PMCF activities in collaboration of the stakeholders
Compiling PMCF plans and communicating the plans in accordance with applicable Medical Device regulations / guidelines
Following up / performing the PMCF activities
Manage timelines and contents with stakeholders / activity owners
Compiling PMCF reports
Miscellaneous
Providing Clinical Evaluation and PMCF input to PMS / PSUR and SSCP
Supporting the Clinical Compliance respondent in audits or represent Clinical Compliance in audits
Respond to Clinical Compliance questions during Notified Body Technical File reviews / Clinical assessments
Proactive global interdepartmental collaboration
Management of external consultants and suppliers
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 profound knowledge and a minimum of 4+ years 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.
Profound knowledge in systematic scientific literature searches, Clinical Research (Clinical Investigations), medical writing and / or dentistry
Profound knowledge of medical device regulations (e. g. MDR, FDA regulations), applicable standards (e. g. ISO 14155) and guidance (e. g. MDCGs, MEDDEV 2.7/1)
Basic knowledge of Clinical Investigations in accordance to EU standards (ISO 14155)
Basic understanding of statistics
Experienced in working with Microsoft Office Software and databases
Pro-active and solutions oriented
Independent, accountable working style
Service-oriented, communicative, and agile Team player
Openness to work in a global setting
Advanced / proficient in English - C1 level (verbal and written)
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!
