Regulatory Affairs & Quality Assurance Manager

Our client is an international pharmaceutical company based in Lugano and authorised with ambitious plans to keep improving and growing. For this exclusive research, we are looking for a successful candidate to fill the position of: REGULATORY AFFAIRS & QUALITY ASSURANCE MANAGER

The purpose of the job is to:


– Managing Quality System: application, control and development.

– Planning strategies and policies of quality in cooperation with the management and in accordance with the applicable regulations (GDP, ISO 9001:2015, ISO 13485:2016, ISO 22716:2007).

– Specifying quality requirements of suppliers and managing supplier qualification.

– Writing quality, regulatory and technical reports.

– Planning quality improvement programs in cooperation with all business functions.

– Managing of complaints, non-conformities, deviations, change controls and CAPAs.

– Supporting the inspections of Swiss authorities and/or customers; answering to inspection reports.

– Managing Regulatory activities to register products in the European Union.

– Responsible for the Surveillance and Vigilance System for drugs and Medical Devices.



 The following skills will be considered a plus:

Being able to qualify as Responsible Person duties described in art. 5, art. 10, art. 14 and art. 15 of the ELO Ordinance on Establishment Licenses (SR 812.212.1).

– Knowledge of Regulatory Affairs related to Medical Devices, cosmetics and dietary supplements.

– Knowledge of the regulatory environment of United States related to Medical Devices and cosmetics.


The Regulatory Affairs & Quality Assurance Manager will report to the Sole Director.




– Education: University or equivalent higher institute graduation in pharmaceutical or biological-natural sciences.

– At least 4 years of professional experience in a licensed production of medicines; proved experience and knowledge of GMP/GDP. Or at least is in possession of qualifications as stated in I-SMI.TI.17.

– Competent in quality management system matters, analysis and control of medicinal products, medical devices, cosmetics and food supplement products.

– Formally trained and up to date on EU GDP requirements, ISO standard 13485, 22716, 9001.

– Ideally age between 36 and 43 years.

Language: fluent English and Italian, written and spoken.


Interested candidates should send their CV by email to Cristina Robotti at or by post to the address below. For further information please call the following number: +41 91 911 30 00.
We thank all applicants for their interest, but only candidates selected for an interview will be contacted.



Luisoni Consulenze SA
Cristina Robotti
Vice Direttrice
Via Balestra 9
6900 Lugano


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