Sr. Lead Specialist, Regulatory Affairs
Sr. Lead Specialist, Regulatory Affairs
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Salary Not Disclosed
1 Vacancy
Job Description
Job Description Summary
A trusted regulatory subject matter expert to provide guidance to the GE HealthCare Monitoring Solutions business focused primarily on patient monitoring in cardiac respiratory neurology hemodynamic and pulse oximetry. You will work within a team of Regulatory Affairs professionals to ensure GE HealthCare establishes best practices in compliance with regulatory requirements. The Senior Regulatory Affairs Specialist will be involved with regulatory activities in the areas such as premarket submissions regulatory intelligence regulatory requirements flow-down advertising and promotion review product labeling compliance etc.GE HealthCare is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition turn ideas into world-changing realities and join an organization where every voice makes a difference and every difference builds a healthier world.
Job Description
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.
Works with a cross functional team to prepare and submit regulatory submissions such as 510(k)s MDR EU Technical Files or submissions to other global regulators such as NMPA TGA etc. for the purpose of obtaining authorization for market launch.
Assesses changes in existing products to and determines the need for new / revised licenses or registrations. Develops plan for timely submission of renewal registrations for applicable countries per business plan to ensure continued product supply in those countries.
Reviews and approves advertising and promotion material to ensure consistency with approved claims and regulatory requirements.
Contributes to writing and editing technical documents.
Researches analyzes integrates and organizes background information from diverse sources for regulatory submissions.
Ensures compliance with pre- and post-market product approval requirements
Supports regulatory inspections as required.
Qualifications/Requirements:
Bachelors degree from an accredited university or college preferred in a Scientific Engineering Regulatory Legal or core Life Science discipline.
4 years experience in a highly regulated industry preferred in Regulatory Affairs or equivalent experience through advanced degree or other relevant education and experience.
Strong verbal and written communication and presentation skills with the ability to speak and write clearly and convincingly in English.
Demonstrated experience and proficiency with MS Office word processing spreadsheet presentation and collaboration applications.
Desired Characteristics:
Demonstrated ability to analyze and resolve problems. Ability to document plan market and execute programs. Established project management skills. A team player and collaborator.
Preferably Regulatory Affairs Certification (RAC) issued by the Regulatory Affairs Professionals Society (RAPS).
Experience in medical device regulatory affairs
Demonstrated life-long learner; eagerness to obtain new skills and knowledge.
We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus and drive ownership always with unyielding integrity.
Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything youd expect from an organization with global strength and scale and youll be surrounded by career opportunities in a culture that fosters care collaboration and support.
GE HealthCare offers a great work environment professional development challenging careers and competitive compensation. GE HealthCare is anEqual 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.
GE HealthCare will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).
While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19 some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees.
Relocation Assistance Provided: Yes
Required Experience:
Senior IC
Employment Type
Full-Time
