Regulatory Affairs Lead
QHR
- מספר מקומות
?Define and monitor external standards and guidelines for the companys activities
?Coordinate, prepare, and review regulatory submissions for domestic and international projects. Prepare and support international submissions and international product releases (CE, FDA, etc.) in accordance with applicable SOPs. Prepare and maintain technical files and other regulatory ation, as necessary, to obtain and sustain product approval.
?Interpret regulatory rules and rule changes to ensure that they are communicated through policies and procedures.;
?Accompany R D projects. Provide regulatory input, review and approve projects inputs and outputs. Participate in product development, as required, to ensure the product follows regulatory requirements.
?Work and communicate closely with company members to assist in obtaining regulatory approvals
?Coordinate, prepare, and review regulatory submissions for domestic and international projects. Prepare and support international submissions and international product releases (CE, FDA, etc.) in accordance with applicable SOPs. Prepare and maintain technical files and other regulatory ation, as necessary, to obtain and sustain product approval.
?Interpret regulatory rules and rule changes to ensure that they are communicated through policies and procedures.;
?Accompany R D projects. Provide regulatory input, review and approve projects inputs and outputs. Participate in product development, as required, to ensure the product follows regulatory requirements.
?Work and communicate closely with company members to assist in obtaining regulatory approvals
Requirements:
?A bachelors degree in a relevant field.
?At least 5 years experience in regulatory affairs, at a Medical Device Company.
?Familiarity with global regulations and standards.
?Effective communication skills both verbally and in writing.
?Good analytical skills.
?High ability to work independently.
?Self-motivated and proactive.
?Fluent in English with excellent writing skills.
?Excellent computer skills, including a working knowledge of Microsoft Office applications
?A bachelors degree in a relevant field.
?At least 5 years experience in regulatory affairs, at a Medical Device Company.
?Familiarity with global regulations and standards.
?Effective communication skills both verbally and in writing.
?Good analytical skills.
?High ability to work independently.
?Self-motivated and proactive.
?Fluent in English with excellent writing skills.
?Excellent computer skills, including a working knowledge of Microsoft Office applications
This position is open to all candidates.
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תל אביב - יפו
וויופוינט השמות
Reckitt
Reckitt
דנאל (ביוטק)
בתחום שלי
בתחום שלי
לימודים
אזור אישי
