AdresseAs a leading innovator of women’s health, we at Hologic are empowering people to live healthier lives everywhere, every day.
Our quality and regulatory affairs team is responsible for keeping abreast of new, changing and existing regulatory requirements. They lead the development and implementation of a global vision for regulatory affairs, government relations, quality management and market access, to influence with strategic and operational plans.
As the Expert Technical Documentation and Regulatory Affairs Specialist here at Somatex part of the Hologic group, you will be responsible for the creation and maintenance of technical documentation according to the relevant Medical Device Regulations. You will be responsible for:
- Creation and maintenance of technical documentation according to Medical Device Regulation 2017/745
- Function as PRRC- Person Responsible for Regulatory Compliance according to Medical Device Regulation 2017/745 Article 15 regarding:
- preparing and keeping up to date the technical documentation and the EU Declaration of Conformity,
- Communication with the notified body or authorized consultants on relevant topics
- Collaboration in the maintenance and further development of the QM system according to DIN EN ISO 13485 as well as 21 CFR 820
- Creation, maintenance and revision of QM documents
- Processing and follow-up of CAPAs
- support of international registration of medical devices in different countries
- Maintenance/update of establishment registration with FDA and other international regulatory bodies as required.
You will have:
- Minimum 2 years of experience in the creation of technical documentation for medical devices
- Minimum 2 years of experience within Regulatory Affairs
- Knowledge of QM systems for medical devices
- Experience with Medical Device Regulation 2017/745
- Proficient business level German and English written and verbal language skills
- Familiarity with requirements of FDA’s 510K, UKCA regulations
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