QA/RA Consultants - Electro-Medical Devices - Netherlands

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QA/RA Consultants – Electro-Medical Devices – Netherlands

Type: Permanent

Salary: 60-80k EUR

Sector: Software/Active Medical Devices.

Location; Netherlands

Job title: Senior Consultant / Product Specialist – Software and Active Devices

Reports to: VP Regulatory Affairs / Principal Consultant? Netherlands

Scope: Seeking consultants at different career levels with experience in regulatory compliance, quality assurance, regulatory affairs and/or auditing in the area of medical devices.

Profile:

Their consultants work depending on their background and experience on a range of projects from supporting our clients with compliance issues, building quality systems in compliance with ISO 13485, building technical files for CE (Europe) or 510(k) submissions (USA), provide technical support in IEC 60601 compliance, providing strategic advise on registration and market access of medical devices, doing audits and giving training or workshops.

Responsibilities:

Provide specialist consulting services on medical device regulations, quality management system requirements, compliance to standards and strategic support to medical device manufacturers;

Set up of Technical Documentation and Design Dossiers in support of the CE marking process and other International Regulatory compliance processes.

Conduct/advise on validation studies or other technical expert studies for clients in support of regulatory submissions.

Provide medical device expertise in areas of competence to colleagues in the wider Group.

Support to obtain, maintain or expand market access to various markets such as European Union, USA, Brazil, etc.

Provide “Technical Sales/Networking” support to the commercial team and promote company.

Provide in-house and external training in active and electro-medical device and software ?development and other areas of expertise ?Key responsibilities & accountabilities

Deliver consultancy projects in the broadest sense to manufacturers of active medical devices and software, in the areas of development activities, regulatory requirements, quality management system and compliance to standards.

Work within technical, quality and regulatory teams of the client as well as with colleagues as required to provide consultancy services within the area of expertise.

Requirements:

• Technical education with a BSc, MSc or PhD degree in physics, electro-technology, electronics or similar


• Minimal 5 years technical working experience in a medical device company (R&D or manufacturing)


• Quality and/or regulatory experience with medical devices (would be welcome, not required)


• Pragmatic, enjoying a mix of activities in technology, business processes, regulatory affairs.


• Communicative and service oriented


• Strong organizational skills, detailed oriented


• Fluent in Dutch and English


• Working permit and driver’s license for The Netherlands

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