Job Detail

Senior Regulatory Affairs Manager (m/w)

Inseriert am: 31.08.2020

In order to strengthen our team in Basel, we are looking
for a new colleague at the earliest possible date as a


Senior Regulatory


Affairs Manager (m/w)


Tasks
8+ years experience in regulatory
affairs and in international approvals in
Ensuring that regulatory requirements the field of medical devices or
for the approval of medical devices are pharmaceuticals. Experience in quality
met during the product development management and / or product
process
development is an advantage
Support and consulting for research & TÜV certifi ed Regulatory Manager or
development and brand management equivalent education
in the interpretation of regulatory
requirements throughout the entire Knowledge of MDD 93/42/EEC as well
lifecycle of the products and ensuring as MDR 2017/745 (product
that the technical documentation of classification, definition of applicable
the products complies with the standards, conformity assessment
respective requirements for medical procedures)
devices
Experience in working in
Communication of new regulatory interdisciplinary teams
approval requirements to research &
development as well as brand Excellent MS-Office knowledge,
mangement and support in the experience in handling document
implementation thereof
control and ERP systems (e.g. SAP)
Participation in interdisciplinary German and English proficiency written
product development teams
and spoken, additional languages are
Assessment of products with regard to an advantage
their risk potential
Responsibility for the regulatory Your prospects
content of product-related information
and its release
Challenging job in an exciting
Conducting conformity assessment environment
procedures for the products and International employer with team-
initiating the preparation of the oriented working atmosphere
declaration of conformity
Attractive employment conditions
Support of international product
registration
Do your professional and personal
Support in the preparation and qualifi cations match our requirements?
execution of audits
We look forward to receiving your
Support in continuing improvement of application.
quality procedures and regulatory
processes
CAMLOG Biotechnologies GmbH
Frau Barda Abdija
Margarethenstrasse 38
Your Profi le
CH-4053 Basel
jobs@camlog.com
Scientifi c, medical or engineering
background, or corresponding industry
experience
Are you looking for a new challenge in a successful company? At CAMLOG, we produce innovative products for
implant dentistry. With the CAMLOG® implant system, we are one of the market leaders in our industry.
We owe this position not only to customers who value us as a reliable partner, but also to our highly motivated
employees. They ensure the continuous technical and qualitative development of our products and processes.

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