We’re looking for an experienced and energetic manager to lead and oversee regulatory and quality operations in our most critical growth phase as we prepare to commercially launch our product – you will be heading the international registration processes of our products and the feasibility, action plan, and implementation of EU Medical Device Regulation requirements. To achieve this, you should have in-depth knowledge of the EU MDR regulations and managerial experience for regulatory affairs in the technology and healthcare sectors.
If you feel comfortable ensuring the regulatory compliance of revolutionary medical technology developed by highly motivated and visionary people in a growing deep-tech start-up – Powerful Medical is the right place for your next challenge.
- Blocking of products that do not comply with the relevant regulations
- Autonomous contact and communication with authorities in the event of a vigilance case
- Preparation of all necessary reports within the post-marketing surveillance activities
What you’ll do
- Inspection of the products based on the specifications of the QM system
- Prepare our products for international registrations
- Release of products for sale
- Ensure the compilation and perform the continuous updating of the QM system according to ISO 13485
- Ensure the compilation and continuous updating of the technical documentation (Annex II and III MDR)
- Ensure the issuance and continuous updating of the EU Declaration of Conformity
- Ensure the execution of the necessary notifications to the authorities in the context of vigilance cases in compliance with the notification formalities and the respective notification deadlines
- Ensure adequate and regulation conforming post-marketing surveillance
- Ensure the preparation of the resulting internal and external reports and their timely transmission to the competent authorities or European databases in due time
- Ensure the initiation and implementation of any necessary measures resulting from the post-market surveillance activities.
- Ensure the preparation of the declaration according to Annex XV, Chapter II, Section 4.1 for devices for clinical investigations.
What you need
- Professional English proficiency level
- A diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognised as equivalent by the Member State concerned, in law, medicine, pharmacy, engineering or another relevant scientific discipline, and at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices; or
- Four years of professional experience in regulatory affairs or in quality management systems relating to medical devices.
- In-depth knowledge of the EU Medical Device Regulation
- Experience with Software as a Medical Device
- Experience with AI/ML in medical devices (nice to have)
- Experience with FDA medical device approval (nice to have)
- Experience in growing and managing high-performing and multi-disciplinary teams
- Experience in effectively managing a fast-growing organisation, ability to assess current needs, and set up a flexible organisational structure
- Clear and effective communication skills – verbal, written, listening
- Be high-energy and action-oriented balanced with critical thinking and organisation skills
- Display, encourage and inspire a culture of excellence across the entire organisation