- 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
- 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
- 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
- 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
- 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 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)
-
Clinical Compliance Manager
vor 1 Tag
JobCloud PPP Ballaigues, SchweizThe 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 t ...
-
Compliance & Release Associate Manager (M/F/d)
vor 3 Wochen
Merck KGaA Darmstadt Germany Aubonne, SchweizExprimez votre talent avec nous · Vous voulez explorer, franchir des obstacles, faire des découvertes ? Nous savons que vos projets sont ambitieux. Les nôtres aussi Dans le monde entier, nos collègues ont la passion de l'innovation scientifique et technologique qui enrichit les ...
-
Manager Qc Compliance
vor 2 Wochen
Incyte Corporation Yverdon-les-Bains, Schweiz**SUMMARY** · The Manager QC Compliance is responsible for ensuring QC processes are compliant to regulatory and Incyte requirements as well as contributing to their continuous improvement based on best industry practices. The activities include (but is not limited to) responsibi ...
-
Senior Manager Clinical Compliance
vor 4 Wochen
Dentsply Sirona Ballaigues, SchweizRequistion ID: 76199 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 compre ...
-
Mos Compliance Associate Manager
vor 3 Wochen
Merck KGaA Corsier-sur-Vevey, SchweizWork Your Magic with us · Ready to explore, break barriers, and discover more? We know you've got big plans '" so do we Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electro ...
-
Manager Synchronization Hub Compliance
vor 2 Wochen
Philip Morris International Lausanne, SchweizPLEASE UPLOAD YOUR APPLICATION IN ENGLISH. · Be a part of a revolutionary change. · At PMI, we've chosen to do something incredible. We're totally transforming our business and building our future on one clear purpose - to deliver a smoke-free future. · With huge change, comes hu ...
-
Manager Achats Indirects Et Compliance
vor 4 Tagen
Jaeger LeCoultre Le Sentier, SchweizCode de référence: 92809**Manager Achats Indirects et Compliance**: · - Le Sentier, VD, CH- Fixed TermDepuis sa création, Jaeger-LeCoultre a fait de la précision un art à part entière, en trouvant le parfait équilibre entre savoir-faire pointu et sens artistique, sophistication e ...
-
Compliance Manager
vor 4 Wochen
Swissquote Gland, SchweizBuilding the bank of tomorrow takes more than skills. · It means combining our differences to imagine, discuss, code, develop, test, learn... and celebrate every step together. Share our vibes? Join Swissquote to unleash your potential. · We are the Swiss Leader in Online Banking ...
-
Compliance Manager
vor 4 Wochen
SwissQuote Gland, SchweizCompany DescriptionBuilding the bank of tomorrow takes more than skills. · It means combining our differences to imagine, discuss, code, develop, test, learn... and celebrate every step together. Share our vibes? Join Swissquote to unleash your potential. · We are the Swiss Lead ...
-
Incyte Morges, SchweizOverview · Summary · The Manager/Senior Manager Global Quality Compliance and Performance is a member of the Global Quality team assuring the oversight of Incyte Quality compliance and driving quality performance at Incyte, spanning the different GxP disciplines (pre-clinical an ...
-
Incyte Morges, SchweizAperçu · Summary · The Manager/Senior Manager Global Quality Compliance and Performance is a member of the Global Quality team assuring the oversight of Incyte Quality compliance and driving quality performance at Incyte, spanning the different GxP disciplines (pre-clinical and ...
-
Engineer R
vor 2 Wochen
JobCloud PPP Ballaigues, SchweizEngineer R & D · Senior R&D Engineer · The Senior R&D Engineer collaborates closely with the Project Managers and multidisciplinary teams by supporting with technical knowledge and competencies. · The position has a strong bias towards laboratory testing, comprising the adaptatio ...
-
Senior R&D Engineer
vor 3 Wochen
Dentsply Sirona Ballaigues, Schweiz Paid WorkRequistion ID : 77523 · 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 com ...
-
EHS Manager
vor 2 Wochen
Eaton Le Lieu, Schweiz**_Job Summary_** · **_Job Responsibilities_** · - Set up and maintain an effective EHS management system for the sites according to Eaton MESH programs · - Is responsible for EHS reporting related to the Mont-sur-Lausanne and Le Lieu locations and proper investigation of EHS eve ...
-
Incyte Corporation Morges, SchweizAperçu: · Summary · The Manager/Senior Manager Global Quality Compliance and Performance is a member of the Global Quality team assuring the oversight of Incyte Quality compliance and driving quality performance at Incyte, spanning the different GxP disciplines (pre-clinical and ...
-
Manager Qc Laboratory
vor 3 Wochen
Incyte Corporation Yverdon-les-Bains, SchweizSUMMARY · The Manager QC Laboratory is responsible for the supervision of the QC Laboratory activities, to support analytical method validation, product testings (IPC, DS), raw materials testings, environmental and utilities monitoring. · DUTIES AND RESPONSABILITIES · - Author, r ...
-
Finance Controller
vor 3 Wochen
NetGuardians Yverdon-les-Bains, SchweizDo you thrive in a fast-paced environment, where you gain a tremendous amount of responsibility and experience? Do you want to be part of an entrepreneurial team and work with motivated and extremely driven people? And are you curious or passionate about finance? If so, you might ...
-
Technician Qc
vor 4 Wochen
Incyte Corporation Yverdon-les-Bains, SchweizJob Summary (Primary function) · During the construction and QC laboratory startup phase, the QC technician will participate to equipment setting up. This person will also participate to the documentation preparation linked to QC activities. For the first project phase, the QC te ...
-
Patent Counsel
vor 3 Wochen
Nestlé Orbe, Schweiz Ganztags On-sitePosition Summary · You will integrate Legal R&D, part of the Nestlé Group Legal & Compliance function, enabling and protecting Nestlé R&D Innovations through the provision of pragmatic legal services and business-driven IP protection. · You will join the Coffee & Systems team of ...
-
Central Data Agent
vor 3 Wochen
WE ARE ALL IN Gland, Schweizde l'entreprise · CHALLENGE THE CODE WITH US · Avec Swissquote, venez réinventer un système devenu obsolète. Au revoir dress code, innovation mollassonne et managers inaccessiblesplace à la personnalité, à l'audace et au team spirit. Cet état d'esprit permet à nos développeurs, i ...
Clinical Compliance Manager - Ballaigues, Schweiz - Dentsply Sirona
vor 1 Monat
Beschreibung
The Clinical Compliance Manager is responsible for the following scope:
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
Role and Responsabilities:
Clinical Evaluations
Post-Market Clinical Follow-up (PMCF)
Miscellaneous
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.
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
