Lead Specialist Regulatory Affairs Transfers
Lead Specialist Regulatory Affairs Transfers
Posted on :
20-01-2025
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1 Vacancy
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Monthly Salary
Not Disclosed
Salary Not Disclosed
Vacancy
1 Vacancy
Posted on :
20-01-2025
Job Description
Job Title: Lead Specialist Regulatory Affairs Transfers
Job Location: Wisconsin USA
Job Location Type: Remote
Job Contract Type: Fulltime
Job Seniority Level: MidSenior level
Job Description Summary
In this role you will create and manage global regulatory submissions for Patient Care Solutions products focused on continuity of global manufacturing operations. This will include providing strategic regulatory requirements for product deployment maintenance premarket submissions/registrations and post market compliance.
GE HealthCare is a leading global medical technology and digital solutions innovator. Our mission is to create a world where healthcare has no limits. Unlock your ambition turn ideas into worldchanging realities and join an organization where every voice makes a difference and every difference builds a healthier world.
Job Description
Roles and Responsibilities
Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into worldchanging realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale and you’ll be surrounded by career opportunities in a culture that fosters care collaboration and support.
Additional Information
GE HealthCare offers a great work environment professional development challenging careers and competitive compensation. GE HealthCare 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.
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 COVID19 some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees.
Relocation Assistance Provided: No
In this role you will create and manage global regulatory submissions for Patient Care Solutions products focused on continuity of global manufacturing operations. This will include providing strategic regulatory requirements for product deployment maintenance premarket submissions/registrations and post market compliance.
GE HealthCare is a leading global medical technology and digital solutions innovator. Our mission is to create a world where healthcare has no limits. Unlock your ambition turn ideas into worldchanging realities and join an organization where every voice makes a difference and every difference builds a healthier world.
Job Description
Roles and Responsibilities
- Develops comprehensive regulatory strategies for medical device products focused on continuity of manufacturing operations and under minimal supervision.
- Navigates evolving global regulatory requirements to facilitate and maintain market access. Assesses changes in existing products to determine the need for new / revised global licenses or registrations.
- Identifies regulatory requirements for product launch authors premarket submissions/registrations and performs change assessments in accordance with business timelines.
- Collaborates across the regulatory organization and cross functionally with Engineering Clinical Integrated Supply Chain and Scientific to support global submissions in key markets.
- Reviews and approves advertising and promotion material to ensure consistency with approved claims and regulatory requirements.
- Builds and maintain working relationships with cross functional project teams and provide clear communication on regulatory deliverables.
- Takes initiative in identifying and resolving regulatory holds submissions issues regulatory queries and escalates to management accordingly.
- Bachelor's degree in a Scientific Engineering Computer Science core Life Science discipline or a combination of training and experience demonstrating the equivalent.
- A minimum of 3 years combined work experience in heavily regulated fields such as medical devices pharmaceuticals biologics logistics operations related to import/export compliance.
- A minimum of 1 years’ experience in Regulatory Affairs and operations supporting global compliance.
- Excellent verbal and written communication and presentation skills with the ability to speak and write clearly and convincingly in English tailoring communication methods to customer’s requirements.
- Adept at utilizing research tools and capable of synthesizing complex information to support submissions and decisionmaking processes.
- Strong project management communication and interpersonal skills.
- Demonstrated experience and proficiency with MS Office word processing spreadsheet presentation Adobe Acrobat project management and collaboration applications.
- Experience with supporting manufacturing operations maintaining continuity of such operations and strategic experience in optimizing how products are registered globally.
- Experience with high risk life supporting and lifesustaining products preferred.
- Advanced degree in scientific technology or regulatory affairs disciplines.
- Regulatory Affairs Certification (RAC) issued by the Regulatory Affairs Professionals Society (RAPS).
- Learning oriented and eager to obtain new skills and knowledge. Demonstrates flexibility in understanding new and evolving regulations.
- Humility in understanding but assertive when needed.
Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into worldchanging realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale and you’ll be surrounded by career opportunities in a culture that fosters care collaboration and support.
Additional Information
GE HealthCare offers a great work environment professional development challenging careers and competitive compensation. GE HealthCare 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.
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 COVID19 some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees.
Relocation Assistance Provided: No
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Employment Type
Full Time
Key Skills
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