Careers

Understanding the regulatory requirements in the target countries for medical devices. Interaction with Notified bodies and consulting companies in the target countries. Writing and submitting the registration documents.

Requirements:

• Graduate of a relevant university degree- Must
• Relevant experience in the industry – Must
• Experience in registration in Europe / USA / Canada – an advantage
• High-level English

Applying:

If you find that you are suitable for the job requirements, we would appreciate your sending of your resume directly to: jobs@rs-ness.com

Thank you in advance and good luck

* Appropriate inquiries will be answered

Validation testing and performing (IQ / OQ / PQ)

Writing reports and protocols, coordinating with different interfaces in the company,
supporting projects from the planning stage to execution and delivery to the customer.
Working on several projects in parallel.

Requirements:

A must –

• A Bachelor’s degree in Mechanical Engineering / Chemistry / Biotechnology –
  3 years experience working in the pharmaceutical / biotech / medical device industry

Holds a certificate of practical engineer with relevant experience in the pharmaceutical / food industry

• High level of English
• Knowledge of clean rooms, HVAC systems, water systems, process equipment
• Experience in writing procedures / work and maintenance instructions
• Experience from a pharmaceutical / biotech / medical device company – a significant advantage

Applying:

If you find that you are suitable to the job requirements, we would appreciate your sending of your
resume directly to: jobs@rs-ness.com

Thank you in advance and good luck

* Appropriate inquiries will be answered

Position definition and requirements:

• Defining and writing of validation documents (VP, URS)
• Conducting acceptance tests (IQ / OQ / PQ) in collaboration with engineering,
  laboratory, production and QA personnel
• Supporting the IT activities during deployment of the production systems and embedded computer labs at all stages (from initiation to system retirement)
• Supporting the preparation and installation of the IT infrastructure for the deployment of the systems (communications infrastructure, hardware, users management, backups, remote connection)
• Periodic reviews of system maintenance and compliance with regulatory requirements
• Close and ongoing work with the engineering, production and lab personnel at the company’s plants, with the IT personnel in the company, and with external suppliers in Israel and abroad

Requirements

BA in the field of Technology, Engineering, Science

Experience in performing testing of computerized systems

3 years of experience in QA, IT at an industrial company

High level English

Working in a regulatory environment and good familiarity with regulatory requirements: GAMP5 / Part 11 / Annex 11 – A significant advantage!

 Applying:

If you find that you are suitable to the job requirements, we would appreciate your sending of your resume directly to: jobs@rs-ness.com

Thank you in advance and good luck

* Appropriate inquiries will be answered

• B.A. in Mechanical Engineering/ Biotechnology/ Life Sciences
• 3 years of experience with medical device Quality and Regulatory requirements (ISO13485, GMP)
• Experience in writing and implementing Quality system comply with ISO13485
• Experience working with R&D and Manufacturing departments
• Familiarity with the Medical Device Directive (MDD) requirements
• Has participated at least once in a CE quality/regulatory audit
• High level English

Applying:

If you find that you are suitable to the job requirements, we would appreciate your sending of your resume directly to: jobs@rs-ness.com

Thank you in advance and good luck

* Appropriate inquiries will be answered