Regulatory Compliance Berater (m/w/d)

Оccupation: Regulatory Affairs Manager

Senior Consultant (m/w/d)

Mitdenker:in search

About us

The BAYOONET Group with locations in Darmstadt, Munich, Berlin, Ludwigsburg and Cologne has been designing tailor-made software and hardware for over 20 years. We are one of the top IT companies in Germany and consist of:

• BAYOOTEC GmbH – we engineer enterprise software (bayootec.com)
• BAYOOMED GmbH – we engineer medical software (bayoomed.com)
• BAYOOSOFT GmbH – we management software (bayoosoft.com)
• BAYOOCARE GmbH – we launch medical devices worldwide (bayoocare.com)
• Mechatronic Medical Engineers GmbH – we engineer medical devices (mechatronic.de)
• Puls Productdesign GmbH – we design industrial products (puls-design.de)
• UID GmbH – we create user experiences (uid.com)

All around 360 employees of the BAYOONET Group have something in common: we are Mitdenker:innen.

To support our team of BAYOOCARE, we are looking for you as a Regulatory Compliance Consultant /Consultant (m/w/d).

Your tasks

You advise both our internal teams and external customers from the medical technology, pharmaceutical and biotech industry. You support our customers in particular in the development and market approval of complex products, digitally connected medical devices and combined medical device combination.

Your diverse range of activities includes:

• Advice on regulatory requirements (MDR, IVDR and the requirements of MDSAP countries)
• Support in the creation and maintenance of technical documentation for medical devices according to regulatory requirements
• Accompanying conformity assessment procedures – especially for medical devices and combination products
• Advice and support in clinical trials as part of test product responsibility
• Stakeholder management and coordination with customers, authorities, designated bodies and partners
• Participation in and management of audits
• Negotiation of quality assurance contracts

Your profile

• Completed studies in a relevant field (medical engineering, natural science, pharmacy, law, etc.)
• Knowledge of regulatory requirements for medical devices and/or medicines (MDR/IVDR, ISO 13485, 21 CFR, GxP etc.)
• Experience in regulatory affairs or compliance consulting, ideally focusing on combined products or digital medical technology
• Communication and consulting skills – both internally and externally to customers
• Structured and analytical methods as well as a high customer and result orientation
• German and English language skills

In addition to your professional and practical know-how, you have a sovereign and empirical appearance. In addition, social competence is characterized in the form of reliability, commitment and flexibility, and you demonstrate both a high degree of autonomy and a high team capability. Above all, you are one:e Mitdenker:in.

Benefits for Mitdenker:innen

• Multifaceted teams from Mitdenker: inside and outside, working together collaboratively and at eye level
• A versatile range of tasks with direct responsibility in strategic and operational customer consulting
• The opportunity to participate in innovative products such as connected medical devices
• An environment that promotes innovation, initiative and responsibility
• Positive error culture in which we celebrate successes and continuously improve our cooperation
• Growing holiday quota by company
• Flexible working hours and models where no working hours are lost and the possibility to work remotely
• Individual training and development opportunities in Regulatory Compliance and Consulting
• Performance-oriented payment with option for occupational retirement
• height adjustable multiscreen workstations as well as powerful laptops
• Best accessible locations by public transport and by car
• And of course modern, bright offices, theme meeting rooms, fresh fruit, coffee and drinks

Did we awaken your interest?

Then please check out for more information on our career page or send your application documents to [for e-mail see the original ad] with your salary presentation and the earliest possible entry date.

BAYOONET AG | Europaplatz 5 | 64293 Darmstadt | Phone: +[for phone number see the original ad] | www.bayoo.net

Joblocations:

64293 Darmstadt, HESSEN, GERMANY

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