Regulatory Compliance Consultant (m/f/d)

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 networked medical devices and medical device combinations. 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 Consultation and support in clinical trials under 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

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...) Experience in regulatory affairs or compliance consulting, ideally focusing on combined products or digital medical technology Communication and consulting expertise – both internally and externally to customers Structured and analytical methods as well as a high customer and result orientation German and English 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 demonstrates both a high degree of autonomy and a high team capacity. Above all, you are one:e Mitdenker:in.

Multifaceted teams from Mitdenker: inside and inside, 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 pension provision 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