Product Safety Officer (m/f/d) (Engineer - Electrical Engineering)
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Machine translation — original language: German.Show original
Hardly anything is as motivating as success. Da Vinci Engineering is committed to the success of its own employees. Become a part of us!
Product Safety Officer (m/f/d)
Job ID: 22411 Location: Frankfurt am Main
We are looking for smart and innovative employees who want to make a difference. If you want to work in a dynamic team with flat hierarchies, we look forward to meeting you!
Your tasks:
- Scientific and medical safety assessment of individual case reports for medical devices, including assessment of reporting obligations, verification of MedDRA/IMDRF coding, query management, trend analyses, signal identification, as well as the creation of safety assessments and evaluation reports
- Initiation and follow-up of Corrective and Preventive Actions (CAPAs) as well as support in updating risk analyses, Instructions for Use (IFUs), and other safety-relevant documents based on vigilance data
- Creation and maintenance of Post-Market Surveillance and vigilance documents, particularly PSURs, PMSRs, SSCPs, PMS plans, PMCF reports/plans, as well as support with risk management files, Clinical Evaluation Reports (CERs), Clinical Evaluation Plans (CEPs), and the assessment of scientific literature
- Ensuring regulatory compliance through the preparation and accompaniment of audits and authority inspections, continuous audit readiness, implementation of regulatory requirements, as well as communication with authorities and Notified Bodies, including reporting of incidents, FSCAs, and SAEs
- Collaboration in interdisciplinary development, study, and risk management teams, including review of development documentation (e.g., DHF), support of clinical documents, and presentation of safety-relevant topics
- Creation and implementation of training as well as development of training materials and presentations on topics of medical device safety
- Close cross-departmental cooperation for the continuous improvement of medical device safety, vigilance processes, and regulatory conformity
Your profile:
- Completed studies in pharmacy, human medicine, or a comparable scientific discipline; license as a physician or pharmacist is an advantage, doctorate (PhD/Dr.) desirable
- At least 1 year of professional experience in the field of Medical Device Vigilance or product safety for medical devices, ideally in a medical or pharmaceutical environment
- Sound knowledge of regulatory requirements for medical devices, particularly EU MDR 2017/745 as well as national and international regulations; knowledge of FDA regulations (21 CFR 803, 820, 822), MEDDEV/MDCG guidelines as well as ISO 13485, ISO 14155, and ISO 14971 is an advantage
- Comprehensive specialist knowledge in the field of Medical Device Vigilance within the EU as well as experience in dealing with scientific and regulatory requirements
- Confident handling of relevant databases and systems such as LSS MV, Cognos, or JIRA; experience with audits and inspections is an advantage
- Business fluent English skills in speaking and writing
What awaits you ...
- Experience in exciting and international projects
- Continuous salary development
- Da Vinci Corporate Benefits
- Training on the job and language courses
- Appreciation, motivation, and commitment
Contact details for the job advertisement Frau Andrea Cindric Da Vinci Engineering GmbH Hauptstätter Straße 149 70178 Stuttgart +49 711 72240 107 job@davinci.de