Pre-market QAra Professional

Vor 5 Tagen

Bonn, Deutschland Dedalus SA Vollzeit

Vous souhaitez donner du sens à votre métier ?

Vous voulez contribuer à l'amélioration de nos soins de santé ?

Alors rejoignez notre équipe

We are looking for you in our office in Bonn, Köln, Essen or Home based as a

Pre-market QARA Professional (M/F/d)

Your Role includes:
- You will ensure ongoing Quality and Regulatory compliance of products and services- You drive and mange effectiveness of Quality Management System of Dedalus Labor GmbH.-
- You will provide guidance and define regulatory plans and strategies, working with the project core team. You will also be accountable for the implementation of the pre-market regulatory procedures and the compilation of regulatory clearance documentation to achieve timely regulatory clearances- You drive and monitor timely resolution of NC and CAPA records, identifies area for improvement, takes part in the preparation and progress of internal and external audits and supports quality management review, quality training and the document and records management process to maintain and improve compliance

Your Profile:
- Minimum 3-5 years of experience in a regulated industry - preferably medical device, pharmaceutical or related - holding a position in project management, quality management, or quality assurance and regulatory affairs position.- Ability to analyze, understand, and interpret regulations and standards for a more general business audience- Subject matter expert in regulatory affairs with in-depth knowledge of relevant health care quality standards and requirements including ISO 13485, ISO 14971, IEC 62304, IEC 62366, Medical Device Directive, new Medical Device Regulation MDR and Invitro Diagnostics Regulations IVDR.- Knowledge of and experience in:
- Design control regulations and requirements-
- Medical device classification rules and regulations-
- Medical device regulatory submission regulations and requirements-
- Risk management regulations and requirements-
- Software development methodologies and practices-
- CAPA/NCR regulations and requirements-
- Usability, safety and product related standards-
- Awareness of Medical Device product safety and Security Standards including ISO 27001 GDPR (Preferable)- Awareness of other regulation as determined by product availability (including ANVISA, CMDCAS, FDA, SFDA)- Strong problem solving and project management skills;- Excellent communication (verbal and written), research, organizational and interpersonal skills- Ability to work independently towards deadlines and strong attention to detail- QMS tools (CAPA, regulatory clearances, KPIs) (Preferable)- Language Skills: English (upper intermediate or better), German (near native)- High willingness to travel

Our benefits for you:
- A major challenge in an exciting, innovative and international high-tech company- A permanent employment contract for long-term perspective- A competitive salary package complemented by fringe benefits- Flexible working time, adapting to the personal needs and preferences

If you want to be part of our world and future, we'll take you there.

teamdedalus #together4success #dedalusgroup

Severely disabled applicants will be given special consideration if they are equally qualified.

Dedalus Labor GmbH

Human Resources

Konrad-Zuse-Platz 1-3

53227 Bonn

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