CODAN ARGUS AG has been developing, producing and selling Swiss-made technology solutions for infusion therapy for over 50 years. More than a hundred thousand infusion pump systems with associated software and accessories have since proven themselves in clinical operation worldwide in more than 50 countries. Systems from CODAN ARGUS AG stand for quality, reliability, precision and unrivalled user-friendliness. With innovative technologies and a clear vision, CODAN ARGUS is focusing on the digital future. The company is one of the CODAN companies, which are committed to developing a world-leading position in the infusion market. From its location in Baar/CH, CODAN ARGUS, together with CODAN distributors and other distribution partners, serves its customers worldwide.

In order to support the new strategic orientation, we are looking to strengthen our QA&RA team by recruiting a

Regulatory Affairs Manager (m/w) 80 – 100%in medical technology

Your Assignment:• As a Regulatory Affairs Manager, you will accompany our products and processes throughout the entire product life cycle, from the

conception phase to the design process, market launch and subsequent market surveillance with regard to regulatory issues.• Yourrhetoricalanddiplomaticstrengthsincommunicationareasolidbasisforthesuccessfulfulfilmentofyourhubfunctionbetween

Product Management, Development, Production, Quality Assurance and Risk Management.• Your responsibilities will mainly focus on the registration/approval of Class I and IIb medical devices. As well as the monitoring of

existing product approvals, in Switzerland, Europe, the US and worldwide countries, in consultation with Area Sales Management and with the support of local distribution channels.

• You will be responsible for the timely preparation and maintenance of technical documentation (STED), labelling, as well as checking the completeness and correctness of project documentation, for the regulatory support to the Product Managers during the entire product life cycle and for the attainment and maintenance of registrations.

• Worldwide support of vigilance activities of reportable incidents as well as, if necessary, the initiation of required Field Safety CorrectiveActionsareawelcomefieldofactivityforyourlanguagetalent,yournetworkedthinkingabilityandyourflexiblemindset.

• Together with the PRRC, you will ensure the necessary documentation and timely communication with the relevant health authorities.• Your goal is to analyse the international legal and regulatory requirements with prudence and foresight in order to implement them

accordingly. With your proactive and sustainable commitment, you promote awareness and responsibility throughout the company to ensure compliance at the highest level.

• Supporting the proactive data collection and analysis within the framework of post market surveillance for the entire CODAN ARGUS product portfolio on the market rounds off your responsible area of responsibility.

• Participationinofficialinspectionsandauditsbynotifiedbodiesisanotherresponsiblepartofyourareaofactivity.

Your Profile:• You have acquired a higher technical education (FH/TS, Bachelor) with a specialisation in electronics, mechatronics, mechanical

engineering, biomedical engineering or in the natural sciences, or you are still in advanced education.• Alternatively,youhaveauniversitydegreeinthemedicalfieldandbringahighaffinityfortechnologyandmanufacturingprocesses.• Youhaveatleastfourtofiveyearsofprofessionalexperience,furthereducationintheregulatoryenvironmentandexperience

in medical technology of complex technical systems or medicinal products as well as in project management. This ideally in the implementation of conformity assessment procedures (MepV, CE & FDA) and international approvals for medical devices of class IIb or higher.

• We also require a sound knowledge of international regulations and requirements for medical devices, quality management systems and risk management (in particular MDD 93/42, MDR (EU) 2017/745, ISO 13485 and FDA 21 CFR Part 820 as well as ISO 14971, IEC60601-1,IEC62304andIEC62366)inyourqualification.

• YouareperfectlyskilledintheuseofMicrosoftOffice.• Preferably, your native language is German with very good communication skills. Alternatively, English mother tongue is a variant. Youmustbeabletousebothlanguagesinspokenandwrittenformwithconfidenceinnegotiationsandwriting.Thedocumentationlanguage of CODAN ARGUS AG is English. Additional language skills are welcomed.

Your Personality:• You are a team player, solution-oriented and responsible personality with strong moderation skills who likes to work in a structured

and precise manner.• Findingflexibleandgoal-orientedsolutionsinchallengingsituationsisroutineforyou.Tobreaknewgroundandtosearchfornew

paths corresponds to your mindset. New challenges inspire you and you are up to them. • With responsible, goal-oriented and independent work as well as a networked, analytical way of thinking, you make an important

contribution to the success of our rowing team.• Based on a strong entrepreneurial mindset, you set the necessary priorities with a focus on compliance with regulatory requirements

and an effective way of working. The company‘s goals are based on the requirements of our customers, the further development of the company and the safety of the patients.

• Accordingly, you are able and willing to assume the necessary responsibility in your area and thus clearly commit yourself to our company.

• Transparent,addressee-orientedcommunicationaccordingtoempatheticprinciplessupportsbothyourefficiencyandtheeffectiveness of your targeted measures. You have already learned that clear, respectful and unambiguous communication with all stakeholders is a key factor of your sustainable success.

• Self-reflectionandself-confidencearefundamentalcomponentsofyourauthenticpersonality.Youknowhowtoconfidentlyassessyour strengths and integrate your weaknesses into your personality in such a way that they support your further development.

• Self-regulation in the sense of self-care as well as an actively lived resilience are for you positively lived experience values of your career so far, which support your passion in your profession and enable you to lead a happy and healthy life.

• You are looking forward to contributing your strengths in an international working environment of a successful and growing company. Our corporate cultureCODANARGUSAGisacompanythatattachesgreatimportancetoacontemporaryandfuture-orientedcorporateculture.Weliveflathierarchies.Independentandself-regulatedworkwithaneyeongoalsthatcanbeachievedefficientlyoffersplentyofroomforgrowthand further development. Transparent and respectful communication contribute to a pleasant working atmosphere. Flexibility in the sense offindingcreativesolutionsinsteadofproblem-orientedthinkingisoneofthebasicpillarsofouractivelylivedculture.Welookforwardtowelcoming further dynamic and motivated employees to our team.

If we have aroused your interest, we would like to get to know each other. Please send us your comprehensive and complete application including a letter of motivation by email.

Only direct applications will be considered for this vacancy.

CODAN ARGUS AG Human ResourcesMuriel Lang Oberneuhofstrasse 10 CH-6340 Baar personal@codanargus.com https://codanargus.com