27 days old

Regulatory Affairs Leader

GE Energy
חיפה, חיפה 30000
**Job Description Summary**

The Regulatory Affairs Leader provides regulatory strategy to business leadership regarding healthcare industry regulatory requirements for Molecular Imaging products launch, premarket submissions and registrations, and post-market compliance, while working closely with a cross-functional team and healthcare regulatory bodies globally. The Regulatory Affairs Leader brings regulatory expertise and combines it with in-depth understanding of key business drivers to lead a range of regulatory affairs activities in areas such as premarket submissions, project management, regulatory intelligence, regulatory requirements flow-down, advertising and promotion review, etc.



**Job Description**



**Roles & Responsibilities**



+ Provides regulatory leadership for Molecular Imaging (e.g. SPECT/CT, PET/CT) products, including global authorization strategy and planning, pre-market submissions, notified body and quality system audits, and program implementation.

+ Develops regulatory strategy to optimize regulatory submission pathways, taking into consideration business priorities, regulatory requirements (e.g. product testing, clinical data), product claims and country regulatory dependencies to ensure optimized sequencing for submissions.

+ Explains information clearly with the right level of detail for the audience, and works to understand a situation, potential risks, and develop possible solutions; brings team members to consensus around topics within the field.

+ Recognize when additional support from senior levels within Regulatory Affairs is needed to ensure sound decisions are made and risks are minimized.

+ Utilizes technical expertise and judgement to solve problems. Leverages technical skills and analytic thinking required to solve problems. May use multiple internal sources outside of own team to arrive at decisions.

+ Assesses changes in existing products and determines the need for new / revised licenses or registrations.

+ Reviews and approves advertising and promotion material to ensure consistency with approved claims and regulatory requirements.

+ Researches, analyzes, integrates and organizes background information from diverse sources for regulatory submissions. Contributes to writing and editing technical documents

+ Understands and applies regulatory requirements and their impacts for submissions and pre- and post-market compliance



**Required Qualification**



+ Advanced experience in the Quality & Regulatory Affairs. Knowledge level is comparable to a bachelors degree from an accredited university or college.

+ Bachelors degree and minimum of 3 years experience working in a regulated field.

+ Strong communication skills in English (both written and oral).



**Desired Characteristic**



+ Strong communication, project management, and organizational skills.

+ Ability to work independently in fast-paced environment and adapt to change.

+ Ability to prioritize information for data analysis and recognize when additional information and support is needed

+ Team-oriented and responsive to customer needs.

+ Attention to Detail and Results-Oriented.

+ Ability to understand technical documentation and execute associated procedures.

+ Knowledge in Software and / or Multi-disciplinary medical devices (preferred)



**Additional Information**



The job is open to men and women equally



**Relocation Assistance Provided:** No

Categories

Posted: 2021-03-15 Expires: 2021-04-14

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Regulatory Affairs Leader

GE Energy
חיפה, חיפה 30000

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