Director, Patient & Device Safety in Digital Health

Evinova; Boston (MA); Hybride; USD 194 000 - 255 000; Plein temps

Avantages offerts par ce poste

401(k) plan

Health benefits

Résumé du poste

Evinova is seeking a senior scientific lead to drive regulatory strategy and patient safety oversight for our digital health solutions. You will guide evidence generation, risk management, and regulatory submissions across regions, ensuring compliant and safe clinical data collection and digital endpoints.

Join a hybrid team committed to transforming health through digital innovation, with governance-driven development and collaboration across disciplines.

Qualifications

• Extensive knowledge of regulatory frameworks for digital health solutions (FDA/EMA).
• Experience translating clinical needs into data collection tool designs.
• Proven leadership of cross-functional teams in a fast-paced environment.

Responsabilités

• Own the regulatory strategy for digital solutions, including classifications and evidentiary standards.
• Provide scientific and regulatory oversight across concept, design, validation and deployment.
• Oversee risk management and patient safety in solution development and post-deployment.
• Collaborate with QA, Legal, Privacy and Regulatory to ensure compliance across regions.
• Lead evidence generation and governance to support digital health endpoints.
• Represent scientific positions in meetings with health authorities and sponsors.

Connaissances

Regulatory strategy

Clinical safety oversight

Cross-functional leadership

Data interpretation

Program leadership

Communication skills

GxP & regulatory knowledge

Digital health development

Formation

BSc/MSc/PhD in a relevant discipline

Description du poste

Evinova is seeking a senior scientific lead to drive regulatory strategy and patient safety oversight for our digital health solutions. You will guide evidence generation, risk management, and regulatory submissions across regions, ensuring compliant and safe clinical data collection and digital endpoints.

Join a hybrid team committed to transforming health through digital innovation, with governance-driven development and collaboration across disciplines.