Ogen MedTech HR

Do you have a valid driver's license?

YesNo

Are you able and willing to travel daily between client sites located between Rehovot and Haifa?

YesNo

How many years of experience do you have in Quality Assurance (QA) for medical devices?

How many years of experience do you have in Regulatory Affairs (RA) for medical devices?

How many years of combined experience do you have in medical device Quality Assurance and/or Regulatory Affairs?

Have you led QA/RA projects for medical devices that successfully achieved major regulatory milestones (such as FDA submission, CE marking, ISO 13485 certification, or QMS establishment)?

YesNo

Do you have hands-on experience preparing and submitting FDA and CE regulatory submissions for medical devices?

YesNo

Have you managed multidisciplinary teams and had full project ownership (including delivery, timelines, and coordination) for QA/RA projects in the medical device industry?

YesNo

Do you have practical experience with core QMS activities (such as CAPA, nonconformances, change control, audits, complaints, training, and document control) in the medical device industry?

YesNo

Do you have client-facing or consulting experience in the medical device industry?

YesNo

Do you have an engineering degree?

YesNo

Apply — Senior Project Manager for QA/RA Medical Device Consulting Company