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Regulatory And Labeling Project Manager

Expired Job

General Electric Marlborough , MA 01752

Posted 2 months ago

Regulatory and Labeling Project Manager

  • GE Healthcare

  • Experienced

  • Posted 9/19/2018 9:57:32 AM

  • 3179961

  • Job Function: Quality

  • Business Segment: Healthcare Life Sciences

Location(s): United States; Massachusetts; Marlborough

Role Summary:

This position provides regulatory direction to the business regarding regulatory requirements for product launch, submissions, postmarket compliance and associated labeling activities. He / she will be involved with regulatory activities in preparing regulatory strategies, labeling, premarket submissions, postmarket reporting, regulatory intelligence, regulatory requirements flow-down and postmarket compliance (e.g. annual reports, etc.), as applicable.

Essential Responsibilities:

  • Provides regulatory input for product development to ensure compliance to regulatory requirements for target markets

  • Develops regulatory strategies to help guide regulatory submission pathways, taking into consideration regulatory requirements (including product testing, clinical data, etc), product claims and country regulatory dependencies to ensure optimized sequencing for submissions

  • Provides support to teams for drug and device product labeling preparation, revision, change control, and approval using the AMS (Artwork Management System)

  • Prepares regulatory submissions by working across the regulatory organization and cross functionally with other functions and submits premarket submissions to regulatory authorities, as per business timelines

  • Prepares and files regulatory renewal / extension applications to ensure continued market access, per business direction

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

  • Contributes to writing and editing technical documents

  • Researches, analyzes, integrates and organizes background information from diverse sources for regulatory submissions

  • Understands and applies regulatory requirements and their impacts for submissions

  • Ensures compliance with pre- and post-market product approval requirements

  • Supports regulatory inspections as required

  • Performs a broad variety of tasks in support of product and process design as assigned by the departmental manager

  • Supports and encourages a collaborative, open and team based culture across his / her organization and the larger Regulatory Affairs organization

  • Interacts with and represents GEHC in interactions with regulatory agencies

  • Maintain files of current and archived master labeling materials and final printed copies

  • Maintain current knowledge and awareness of US legislation and FDA regulations/guidance that impact labeling and incorporate into labeling activities

Qualifications/Requirements:

  • Bachelor's Degree or a minimum of 5 years work experience

  • A minimum of 5 years experience in the medical device or pharmaceutical industry

  • Minimum of 2 years experience of regulatory project management and regulatory agency interactions

  • Experience of working globally and across different cultures

  • Ability to communicate effectively in English (both written and verbal)

  • Demonstrated experience and proficiency with MS Office word processing, spreadsheet, presentation and database applications

Desired Characteristics:

  • Assertive and willing to make decisions

  • Ability to juggle and prioritize multiple competing priorities and complete tasks on-time

  • Ability to assign clear priorities

  • Tenacious and delivery focused

  • Ability to make sound business judgments

  • Ability to make sound business judgments

  • Ability to juggle multiple competing tasks

  • Ability to set and make clear priorities.

About Us:

There is no other life sciences company quite like GE Healthcare Life Sciences. A $5 billion business with more than
11,000 individuals in over 100 countries, we are at work enabling a new era in medicine. For more than 60 years, GE

Healthcare Life Sciences has globally supported the development and use of new therapies, helping accelerate the

journey from biological understanding to clinical therapy. GE Healthcare Life Sciences works with cutting edge

technology enabling and advancing the discovery, diagnosis and medical treatments of the present and the future.

We are accelerating biology to cell therapy in ways no other company can.

Follow us on Facebook and Twitter and watch our discoveries in action on our YouTube channel.

Learn More About GE Healthcare Life

Sciences

Learn More About Careers at GE Healthcare Life

Sciences

GE offers a great work environment, professional development, challenging careers, and competitive compensation. GE is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.

Locations: United States; Massachusetts; Marlborough

GE will only employ those who are legally authorized to work in the United States for this opening.


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