5 days old

Regulatory Affairs Program Manager

GE Energy
Role Summary:This position provides subject matter guidance to the growing Clinical Accessories business. He/she works within a team of Regulatory Affairs professionals to ensure establishes best practices in compliance with regulatory requirements. The RA Program manager will be involved with regulatory activities in the areas such as premarket submissions, post-market reporting, regulatory intelligence, regulatory requirements flow-down advertising and promotion review, product labeling compliance, etc.

Essential Responsibilities: Provides the regulatory plan, guidance on risk assessment, and required corrective actions to meet regulatory requirements

Leads regulatory team/ resource to ensure timely product registration, regulatory planning for new product introductions and product changes, and assist in maintaining regulatory compliance

Manage Domestic Class II medical device registration whole processes from project kick-off to product launch; To actively contact with external parties such as testing lab, Jiang Su government agency to accelerate the registration processes

Works with a cross functional team closely to ensure the registration files quality and completion on time

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

Develops plan for timely submission of extension registrations per business plan, to ensure continued product supply

Contributes to writing and editing technical documents

Understands and applies regulatory requirements and their impacts for submissions

Ensures compliance with pre- and post-market product approval requirementsSupports regulatory inspections as required

To manage existing product license

To ensure label and IFU regulatory compliance

Qualifications/Requirements: Demonstrated experience and proficiency with MS Office word processing, spreadsheet, presentation, and database applications.

Bachelors degree or above major in material, engineering, biotechnology, pharmacy, or related subject;

English communication in speaking, listening and writing;

Good communication skills;

5+ years working experience as regulatory affairs in medical device company (Ultrasound, ECG, Patient monitor areas) is preferred.

Desired Characteristics: Minimum of 5 years experience medical device regulatory affairs. Jiang Su MPA experience is preferred.

Ability to work independently in fast-paced environment with little supervision.

Ability to adapt to constant change and influence positive change effectively.

Team-oriented and responsive to customer needs.

Down to earthpractical and patient.

About Us:GE (NYSE:GE) drives the world forward by tackling its biggest challenges. By combining world-class engineering with software and analytics, GE helps the world work more efficiently, reliably, and safely. GE people are global, diverse and dedicated, operating with the highest integrity and passion to fulfill GEs mission and deliver for our customers. www.ge.comAdditional Locations:China;JiangSu;Wuxi;


Posted: 2020-07-31 Expires: 2020-08-30

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Regulatory Affairs Program Manager

GE Energy

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