Senior Clinical Development Scientist: Medical Safety Lead

Regulatory Jobs; Bothell (WA); Presencial; USD 149.000 - 237.000; Jornada completa

Descripción de la vacante

Regulatory Jobs is seeking an experienced Senior Clinical Development Scientist/Medical Safety Manager to lead clinical evidence strategy and safety assessments for medical devices. The role partners with investigators and cross-functional teams to advance product development, regulatory documentation, and risk-benefit analyses.

You will analyze trial data, evaluate safety information from multiple sources, and support safety surveillance and regulatory submissions across the product lifecycle.

Formación

• 7+ years of experience in the medical device industry or similar performing medical safety risk assessments and/or conducting clinical research on medical devices.
• Experience in the oral healthcare or dentistry space highly preferred.
• Doctoral degree in Dentistry or Dental Hygiene strongly preferred, OR a PhD in scientific research in the medical devices space.
• Office-based role with in-person presence required.

Responsabilidades

• Support clinical evidence strategy, medical safety activities, and regulatory documentation across the product lifecycle.
• Analyze clinical trial protocols and studies to support development with data integrity and scientific rigor.
• Evaluate safety information from studies, post-market data, literature reviews, and real-world data to identify safety risks.
• Collaborate with cross-functional teams on New Product Introduction projects and safety surveillance.
• Translate clinical and safety findings into clear information for internal stakeholders and external investigators.

Conocimientos

Clinical development strategy

Medical safety risk assessment

Cross-functional collaboration

Scientific communication

Regulatory understanding (ISO/IEC)

Educación

Doctoral degree in Dentistry or Dental Hygiene / PhD in medical devices

Herramientas

GCP knowledge

Regulatory documentation standards

Descripción del empleo

Regulatory Jobs is seeking an experienced Senior Clinical Development Scientist/Medical Safety Manager to lead clinical evidence strategy and safety assessments for medical devices. The role partners with investigators and cross-functional teams to advance product development, regulatory documentation, and risk-benefit analyses.

You will analyze trial data, evaluate safety information from multiple sources, and support safety surveillance and regulatory submissions across the product lifecycle.