Medical Device Clinical Safety Specialist

EINFÜHRUNG

We offer an exceptional opportunity for a professional seeking a new challenge and increased responsibility in the Basel region as a Medical Device Clinical Safety Specialist.

Our client is a leading and innovative company in the life sciences industry, dedicated to advancing safe and compliant medical device and combination product development. Their work is centred around rigorous clinical safety, global vigilance standards, and high-impact clinical investigations. To strengthen their Portfolio Clinical Safety team, we are searching for an experienced Medical Device Clinical Safety Specialist.

AUFGABENBESCHREIBUNG

In this role, you will independently lead safety activities for Class II and III medical devices, providing expert guidance throughout the full lifecycle of clinical investigations. You will contribute strategic safety input to key documentation such as the Clinical Investigation Plan (CIP/Protocol), Investigator's Brochure (IB), and Reference Safety Information (RSI). Working in a multicultural environment, you will collaborate closely with cross-functional teams and act as the primary safety expert for all device-related matters.

Key Responsibilities:

• Lead and oversee all clinical safety and vigilance processes for medical devices.

• Manage adverse event assessment and reporting in compliance with global regulations.

• Ensure accurate development and maintenance of RSI, CIP, and IB safety content.

• Apply ISO 14155 and ISO 14971 to guide safe and compliant clinical investigations.

• Provide expert risk-benefit evaluations for device safety decision-making.

ERFORDERLICHES PROFIL
You bring a Bachelor, Master's, or PhD in a scientific discipline, along with a minimum of three years' experience in medical device clinical safety or biomedical research. You have hands-on expertise with Class II/III device clinical investigations, a strong command of ISO 14155:2020, and demonstrated experience in risk management according to ISO 14971. Experience with combination products is highly desirable.

If you are a motivated Medical Device Clinical Safety Specialist seeking your next professional step in Basel, we look forward to receiving your application.