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LifeBondProvide regulatory support for product-specific activities related to gaining and maintaining market approval in Europe, United States, Canada and other countries worldwide, including compiling data, organizing and preparing regulatory documents.
Key Job Functions (Duties, responsibilities and authorities)
Assist the Vice President of Regulatory Affairs in the development, implementation and maintenance of regulatory systems and activities:
-Provide guidance, draft and manage the preparation of regulatory submissions for assigned products consistent with regulatory policies and regulations.
-Review of information for accuracy, scientific soundness, and regulatory appropriateness before actual submission to the regulatory agencies (FDA, Israel MOH, Design Dossiers for CE mark, License Applications in Canada and/or other foreign countries).
-Preparation and maintenance of the European Design Dossiers, Notification of the company’s clinical investigation to Competent Authorities in Europe; IDE, 510K, PMA; License Applications in Canada and any additional applicable submissions for pre- and post-marketed products.
-Serves as RA representative on product development teams: Identification of the relevant regulatory requirements during the design, development, preclinical and clinical stages of healthcare highly regulated products and post marketing approval. Participates and represents RA in design control and risk management processes, assures product labeling compliance and involves in promotional review process.
-Interpretation of regulatory policies, procedures, and regulations on how they change and/or impact product approvals and submissions.
-Responsible for assuring adequately and timely manner Regulatory Affairs department training of company SOP's and company procedures.
*Qualified candidates can submit their resume in English.
Job Requirements:Experience requirements
Experience of working in medical device and / or the pharmaceutical industry within the regulatory environment (3-5 years’ experience).
* Minimum education required for competent performance: Bachelor’s Degree (science preferred) ( a Master degree would be an advantage) or equivalent direct industry experience
Required skills and abilities:
-Strong written, verbal and listening communication skill.
-Ability to manage multiple projects and changing priorities.
-Ability to follow instructions
-Ability to work effectively in both cross-functional teams and independently.
-Ability to work with a variety of disciplines and levels of staff across departments and the health system.
-Excellent organizational, problem solving, program development, computer skills and team building skills.
-Excellent analytical ability.
-Excellent attention to details.
Required Experience:3-4 שנים
Sub Categories:רגולציה, רישום