Job Description: The Clinical Research Manager defines and owns the clinical evidence strategy for new and updated AI and machine learning algorithms within software‑based digital dentistry solutions. The role ensures that clinical intended use, clinical benefit, and performance claims are clinically and scientifically justified, competitively positioned, and acceptable from a regulatory perspective. The Clinical Research Manager steers clinical research, clarifies the clinical performance specifications for an algorithm based on end-user voice-of-customer, clinical data governance, and clinical validation strategy for AI and machine learning algorithms. Accountabilities: Clinical evidence strategy & competitive landscape: - Evaluate and clarify clinical intended use, clinical benefit, and accuracy acceptance criteria at project initiation for new and updated AI and machine learning algorithms - Review scientific literature and existing FDA 510(k) clearances to benchmark claims and validation approaches - Define clinical evidence roadmaps and required clinical validation studies Clinical data governance & cross-site alignment: - Own clinical data governance across research, training, validation, and regulatory use - Ensure traceability, data integrity, and audit readiness across multiple data collection sites Collaboration with research & innovation: - Collaborate with research teams on new ideas and early feasibility assessments - Ensure research outputs can be leveraged for downstream validation and regulatory submissions Clinical validation & regulatory substantiation: - Partner with software validation, quality, and regulatory teams to design clinically meaningful studies - Show deep understanding of clinical validation study methodologies and statistics. - Substantiate clinical claims and study designs using literature and regulatory precedent Leadership & execution steering: - Act as escalation point for risks related to data quality, study feasibility, and regulatory alignment - Define processes to improve efficiency and effectiveness of clinical evaluations. Job Requirements: Qualifications: Master or doctoral degree in a relevant field (e.g., Biomedical Sciences, Biomedical Engineering, Data Science, Clinical Research) Fluent in English, excellent oral and written communication skills Skills / technical know-how Strong understanding of clinical research methodologies, AI validation principles, and regulatory expectations Ability to critically assess and synthesize scientific and clinical literature Strong cross-functional collaboration and regulatory communication skills In depth understanding of the field of Digital Dentistry solutions Quality minded, focused on details Ability to manage multiple projects and priorities effectively. Critical experience: Experience in clinical evidence generation for medical software or AI-based solutions Experience managing or mentoring clinical project or study roles This role is based in Mechelen with 4x/week onsite requirement. #LI-SM1 Operating Company: DEXIS Envista and its family of companies (Envista) will not accept unsolicited resumes from any source other than directly from a candidate. Envista will consider unsolicited referrals and/or resumes submitted by vendors such as search firms, staffing agencies, professional recruiters, fee-based referral services and recruiting agencies (Agency) to have been referred by the Agency free of charge and Envista will not pay a fee for any placement resulting from the receipt such unsolicited resumes. An Agency must obtain advance written approval from Envista's internal Talent Acquisition or Human Resources team to submit resumes, and then only in conjunction with a valid fully-executed contract approved by the Global Talent Acquisition leader and in response to a specific job opening. Envista will not pay a fee to any Agency that does not have such agreement and written approval in place. Envista is a global family of more than 30 trusted dental brands, united by a shared purpose: to partner with professionals to improve lives. Envista helps its customers deliver the best possible patient care through industry-leading dental consumables, solutions, technology, and services. Our comprehensive portfolio, including dental implants and treatment options, orthodontics, and digital imaging technologies, covers an estimated 90% of dentists' clinical needs for diagnosing, treating, and preventing dental conditions as well as improving the aesthetics of the human smile. Envista companies, including DEXIS, Kerr, Nobel Biocare and Ormco, partner with dental professionals to help them deliver the best possible patient care. Envista became an independent company in 2019. We brought with us the proven Envista Business System (EBS) methodology, an experienced leadership team, and a strong culture grounded in continuous improvement, commitment to innovation, and deep customer focus to meet the end-to-end needs of dental professionals worldwide. Envista is now one of the largest global dental products companies, with significant market positions in some of the most attractive segments of the dental products industry. For more information, please visit www.envistaco.com.

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