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
.
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.
Your Profile:
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.