General Electric Marlborough , MA 01752
Regulatory and Labeling Project Manager
Posted 9/19/2018 9:57:32 AM
Job Function: Quality
Business Segment: Healthcare Life Sciences
Location(s): United States; Massachusetts; Marlborough
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.
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
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
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.
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
Learn More About Careers at GE Healthcare Life
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.