Clinical Compliance Manager
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.
Role 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!
Kontakt
Sandrine Falco
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