We are always eager to meet motivated people who share our vision and wish to be part of our team.

To meet our clients’ expectations through the development, implementation, and delivery of their products we are currently looking to add to our team, the following:

RAQA Professionals

Job Description:

Prepare requested documents and design dossiers in support of CE marking (MDR or IVDR), FDA submissions including 510(k), PMA, Q-subs, or similar approval processes worldwide.

Among your daily duties you may be requested to  

 

  • Define regulatory strategies and pathways.

  • Create Technical File/Documentation for all device classes and various geographies.

  • Prepare & submit global registrations worldwide: coordination and preparation of document packages for regulatory submissions.

  • Lead Regulatory and Risk Management processes.

  • Support design and development of products from a regulatory perspective.

  • Develop Design History Files

  • Advise on standards, labelling and UDI requirements.

  • Lead and manage processes such as sterilization validation, cleaning validation, biocompatibility etc. – both planning and managing the process to success

  • Lead and manage establishment of QMS

  • Participates and/or lead internal and external audits i.e. FDA inspections, notified body audits according to ISO13485, EUMDR, MDSAP.

Desired experience and skills:

 

  • Minimal 5 years working experience in the field of Medical Devices including Systems, AI, SaMd, imaging, Implants etc.

  • Knowledge of Medical Device Regulations (CE, FDA, PAL, TGA, etc.) and/or Quality Assurance

  • Ability to mentor, develop and engage staff, monitor performance standards and deliver results. Effective communication, collaboration and change management skills.

  • Technical or scientific degree (BSc, MSc or PhD) 

  • Fluent in English.

  • Willing to travel abroad

RA Engineers for design RAQA

 

Job Description:

 

  • Assist in the creation of Technical File/Documentation for all device classes and various geographies.

  • Prepare & submit global registrations worldwide

  •  Coordinate and prepare document packages for regulatory submissions.

  • Participate in Risk Management processes

  • Support design and development of products from a regulatory/Quality perspective.

  • Develop Design History Files

  • Advise on standards, labelling and UDI requirements.

  • Execute processes such as sterilization validation, cleaning validation, biocompatibility etc.

  • Be involved on the establishment of QMS

  • Participate in internal and external audits i.e. FDA inspections, notified body audits according to ISO13485, EUMDR, MDSAP.


Desired experience and skills:

 

  • 2+ years’ experience working in the field of Medical Devices including Systems, AI, SaMd, imaging, Implants etc.

  • Knowledge of Medical Device Regulations (CE, FDA, PAL, TGA, etc.) and/or Quality Assurance Communicative and service oriented, supporting a wide variety of clients from small start-ups to larger firms

  • Have a strong organizational skill, be detailed oriented and able to deal with various projects at the same time

  • Technical or scientific degree (BSc, MSc or PhD) 

  • Fluent in English.

  • Willing to travel abroad

QA Engineers

 

Job Description:

  • Perform Vendor management, non-Conformity processes creation and follow-up as well as CAPA Management and

  • Manage engineering change processes

  • Review DHR and Environmental/Product Microbial Testing

  • Maintain and collaborate records management and control

  • Update procedures and forms

 

Desired experience and skills:

  • 3-6 years’ Experience with Medical Devices in the following areas:

-   DHF

-   Risk Management processes

-   IQ, OQ, PQ of various processes – production processes, clean room etc.

  • Ability to learn a D/P FMEA and be able to identify the requirements of a component from the drawing

  • Good human relations – needs to work closely with company engineers, suppliers, and sub-contractors

  • Knowledge and understanding in technical processes and risk evaluation

  • Technical or scientific degree (BSc, MSc or PhD) 

  • English - High Level

Clinical Writers

Job Description:

Prepare Clinical and Regulatory documents such as literature reviews/ CER / PMS / PMCF for

MDR / IVDR requirements and for FDA submission files

Desired experience and skills:

  • At least 3 years' experience in a medical device company / consulting office

  • Familiarity with the use of online literature databases

  • Ability to interpret, evaluate, and communicate scientific and clinical data

  • Flexibility to work with a variety of technologies

  • Advanced degree in a life sciences or clinical discipline

  • English at a mother tongue level
     

For additional information on posting above and to send your CV please mail to hr@hamada.co.il