(Senior) Regulatory Affairs Manager - Substance Based Medical Devices (m/w/d)
Are you interested in working in an owner-managed, family-orientated, medium-sized organization? Do you enjoy short decision-making paths and the freedom to implement your own ideas? Is a hands-on approach to leadership appealing to you? If your answer to these questions is yes, then look no further!
Your responsibilities as the new (Senior) Regulatory Affairs Manager:
The preparation of international approval documents for substance-based medical devices (OTC class I - II), and the corresponding European and International registration processes.
The review and approval of approval documentation.
The maintenance of the company's regulatory compliance.
Relevant contact person for notified bodies/authorities, and internal/external customers regarding regulatory-related topics.
Responsibility for acting as the company's PRRC (§15 MDR) for regulatory aspects (technical documentation, post-market surveillance, reporting obligations).
Entrusted with leading responsibilities in interdisciplinary projects, as well as the technical guidance of more junior colleagues.
What awaits you as the new (Senior) Regulatory Affairs Manager?
Flexible working arrangements.
The possibility to work remotely (up to 90%).
A strong sense of creative freedom, allowing you to use your strengths optimally.
The possibility to work with global leading, cutting-edge pharmaceutical and medical device organizations.
Extremely flat hierarchies, with short decision-making paths.
Working in a family-orientated, friendly environment.
International customers and varied tasks
Company pension scheme
Subsidized canteen, with access to free fruit and drinks.
In-house fitness programs.
The ideal Director (Senior) Regulatory Affairs Manager would have the following qualifications:
Successfully completed a university degree in a scientific or technical field (or compatible qualifications).
Several years of working experience within the field of regulatory affairs for medical devices at national and international levels.
An in-depth understanding of all relevant standards, regulations, and requirements (MDD/MDR, ISO 13485, etc.).
A flexible, entrepreneurial work style paired with a structured and analytical way of thinking.
Ability to assess regulatory risks/benefits and applicable guidance.
Excellent command of both the English and German languages.
Willingness to travel up to 10%
I am looking forward to receiving your application and learning more about your profile!