Aktuelle Jobs im Zusammenhang mit Regulatory Affairs and Quality Management Specialist - Bochum, Nordrhein-Westfalen - Atlas medical Technologies GmbH
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Regulatory Affairs and Quality Management Specialist
vor 3 Monaten
ATLAS medical technologies GmbH is an innovative enterprise focused on the development and distribution of advanced navigation systems for medical professionals in the fields of interventional radiology and orthopedics. Our cutting-edge 4D laser navigation technology enhances operational efficiency and facilitates more accurate instrument navigation, leading to less invasive procedures and reduced radiation exposure for patients.
Key Responsibilities- Developing, reviewing, and maintaining technical documentation in compliance with the Medical Device Regulation (MDR) for Class I and IIa medical devices.
- Strategizing, gathering, and executing regulatory requirements and approval processes within the EU and on an international scale.
- Engaging with notified bodies and regulatory authorities.
- Preparing documentation specific to approvals in various countries.
- Conducting market surveillance for medical devices.
- Supporting the maintenance and enhancement of the Quality Management System (QMS) in accordance with ISO 13485:2016 and EU-MDR 2017/745, as well as FDA CFR 21 Part 820.
- Fostering awareness and providing training to staff regarding regulatory obligations.
- Planning, executing, and assessing both external and internal audits, in addition to supporting development initiatives and feasibility studies.
- A degree in Regulatory Affairs or Quality Management, complemented by a minimum of 3 years of relevant experience in regulatory affairs or quality management (ISO 13485, CFR 21 Part 820, MDR, MDD).
- Knowledge of FDA approval processes; experience as a Quality Manager or Regulatory Affairs Manager in a startup setting is advantageous.
- Proficient in written and spoken English, with strong skills in MS Office applications.
- Diverse and engaging responsibilities within a dynamic medical technology startup environment.
- An opportunity to contribute to the evolution of healthcare solutions.
- Competitive compensation and flexible working arrangements.
- Potential for career growth within Quality Management.
We are eager to receive your application and potentially welcome you to our organization.
