Regulatory Lead EU
il y a 1 semaine
At BSI, we are seeking a highly skilled Regulatory Lead EU to join our team. As a key member of our Regulatory Services department, you will play a critical role in ensuring our conformity assessment activities and certification processes are compliant with the latest Medical Devices Regulations.
Key Responsibilities:- Provide regulatory support to the Head of Notified Body IVDR in the establishment and maintenance of designations as a Notified Body for the applicable Medical Devices Regulations.
- Responsible for conformity assessment and certification activities related to the scope of the designations the Notified Body operates under, ensuring compliance with applicable regulatory requirements.
- Support Compliance and Risk, Human Resources, and Legal with processes related to legal status, organizational structure, independence and impartiality, confidentiality, liability, and financial requirements.
- Work in collaboration with Designating/Competent Authorities and participate in coordination activities.
- Support Global Quality and Accreditation in the maintenance of accreditation.
- Thorough knowledge of Medical Devices Regulations and related Guidance documents.
- Experience in Medical Device Industry, including Quality Management System processes (ISO 13485) and R&D – Product Development and Manufacturing processes, Risk management Process, and Regulatory aspects of Device Certification/Registration.
- Conceptual and analytical thinking, efficiency, and results orientation.
- A team player with good relationship-building skills internally and externally with authorities and clients and other stakeholders.
- Broad technical understanding of client industry products (materials, processing, assembly, clinical use of products).
- General knowledge of business principles and operating practices (commercial awareness).
- Ability to understand and interpret legislation and input to policy.
- A dynamic and collaborative work environment.
- Opportunities for professional growth and development.
- A competitive salary and benefits package.
We are an equal opportunities employer and welcome applications from all qualified candidates. If you are a motivated and experienced professional looking for a new challenge, please submit your application.
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Regulatory Lead EU
il y a 2 semaines
Metz, Grand Est, France BSI Temps pleinJob Title: Regulatory Lead EUAt BSI, we're seeking a highly skilled Regulatory Lead EU to join our team. As a key member of our Regulatory Services department, you'll play a crucial role in ensuring our conformity assessment activities and certification processes meet the highest standards of regulatory compliance.Key Responsibilities:Provide regulatory...
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Regulatory Lead EU
il y a 2 semaines
Metz, Grand Est, France BSI Temps pleinJob Title: Regulatory Lead EUAt BSI, we are seeking a highly skilled Regulatory Lead EU to join our team. As a key member of our Regulatory Services department, you will be responsible for providing regulatory support to our Head of Notified Body IVDR in the establishment and maintenance of designations as a Notified Body for the applicable Medical Devices...
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Regulatory Lead EU
il y a 2 semaines
Metz, Grand Est, France BSI Temps pleinJob Title: Regulatory Lead EUBSI is seeking a highly skilled Regulatory Lead EU to join our team. As a key member of our Regulatory Services department, you will be responsible for providing regulatory support to our Head of Notified Body IVDR in the establishment and maintenance of designations as a Notified Body for the applicable Medical Devices...
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il y a 3 jours
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il y a 3 semaines
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