Regulatory Affairs Manager
Job Title: | Regulatory Affairs Manager |
Contract Type: | Permanent |
Location: | Basel, Switzerland |
Industry: | |
Salary: | Negotiable |
Start Date: | ASAP |
Reference: | ID 2083_1592486430 |
Contact Name: | Michael Burgstaller |
Contact Email: | m.burgstaller@sciproglobal.de |
Job Published: | June 18, 2020 14:20 |
Job Description
Wir unterstützen unseren Schweizer Partner dabei für einen Schweizer Kunden einen Regulatory Affairs Manager zu suchen!
The Client:
An outstanding Swiss Medtech Company.
Your Tasks:
- Ensuring that regulatory requirements
for the approval of medical devices are
met during the product development
process - Supporting and advising brand
managers throughout the entire
lifecycle of the products in regulatory
terms and ensuring that the technical
documentation of the products
complies with the regulatory
requirements for medical devices - Assessment of all products with regard
to their risk potential - Responsibility for the regulatory
content of product-related information
and its release - Conducting conformity assessment
procedures for the products and
initiating the preparation of the
declaration of conformity
Market release of medical devices
Support of international registration
submissions - Support in the preparation and
execution of audits
Support and consulting for research &
development and brand management
in the interpretation of regulatory
requirements - Communication of new regulatory
approval requirements to research &
development as well as brand
management and support in the
implementation thereof - Participation in the respective product
development teams
- Scientifi c studies, or studies in
engineering, or studies in the fi eld of
medicine, or corresponding industry
experience - 3 years experience in regulatory aff airs
and in international approvals in
the fi elds of medical technology or
pharmaceuticals, experience in quality
management and / or product
development is an advantage - Knowledge of MDD 93/42/EEC (product
classifi cation, defi nition of applicable
standards, conformity assessment
procedures) and other relevant
regulations (e.g. the future MDR
2017/745) - Experience in working in
interdisciplinary teams
Excellent MS-Offi ce knowledge,
experience in handling document
control and / or ERP systems (e.g. SAP)
is an advantage - German and English profi ciency written
and spoken, additional languages
are an advantage
Contact:
m.burgstaller@sciproglobal.de

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