Regulatory & Clinical affairs specialist

Ihre Aufgaben

We are looking for a talented Regulatory & Clinical affairs specialist to work from our office in Ziporit, Israel and become an integral part of our team as we seek to achieve our company mission.

Job description and responsibilities

• Conduct clinical studies needed to complete submissions/ dossiers for crop approvals

• Design and conduct studies in order to assure product safety and effectiveness

• Provide detailed reports on study results to regulatory agencies

• Plan and conduct trainings

• Ensure studies go along with guidelines used to determine validity

• Responsible for processing registration with the Ministry of Health or foreign health agencies/ authorities

• Responsible for implementing regulatory requirements for clinical and post market surveillance

• Develop and update new policies, as appropriate, for processes and procedures relating to the clinical evaluation process

• Responsible for Clinical evaluation plans (CEPs) and Clinical Evaluation

• Reports (CERs) drafting

• Responsible for Clinical literature search protocols and reports

• Participate in and support audits and responses to audit findings as appropriate

• Evaluate the safety and performance and benefit/risk profile of a device over its lifecycle to provide strategic guidance on regulatory requirements and ensure clinical data and clinical evaluations activities & documentation for pre-market products are completed as per the design control process and procedures

Ihr Profil

• PhD in Bio Medical engineering or similar, or M.Sc. with proven research experience

• 2 years' experience in RA & CA in Medical device industry

• Knowledge in European/CE and FDA regulations, including ISO13485

• Knowledge in risk Management according to ISO14971

• Multitasked, independent, punctual and accurate with excellent organizational skills

• Team oriented, collaborative, good personal relationships

• Language: English - High level

Kontakt

Suitable candidates are requested to forward their resume and a cover letter to: hr@alphaomega-eng.co