General Electric Company

Regulatory Affairs Manager

General Electric Company$110K — $130K *
Pharmaceuticals & Biotech
8 - 10 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's Degree in a Scientific or Engineering discipline or 12 years work experience
  • 8+ years in Regulatory Affairs / Quality Assurance
  • 8+ years in the medical device or pharmaceutical industry
  • Strong oral and written communication skills
  • Advanced degree in scientific, technology, or regulatory disciplines (desired)
  • Regulatory Affairs Certification (RAPS) (desired)

Responsibilities

  • Provide regulatory strategy and direction for product launch and compliance
  • Develop global regulatory strategies for product registrations
  • Assess changes in existing products for licensing needs
  • Review advertising and promotional materials for regulatory compliance
  • Lead regulatory inspection support and inquiries from authorities
  • Act as a best practice resource in regulatory affairs
  • Use judgment to solve moderately complex tasks or problems

Benefits

  • Not specified in the job listing
Full Job Description
Job Description Summary
This position provides strategic regulatory leadership for the Invasive Cardiology programs. This includes leading major regulatory projects, programs and regulatory submissions, working closely with a cross-functional team and global regulatory bodies. The Regulatory Affairs Manager will be involved with regulatory activities such as global premarket submissions and registrations, device classifications and determinations, project management, business communication and strategy, risk management, post-market reporting, regulatory intelligence, regulatory requirements flow-down, advertising and promotion review, product labeling compliance, etc.

Job Description

Roles and Responsibilities
  • Provides regulatory strategy and direction to the business regarding healthcare industry regulatory requirements for product launch, premarket submissions/registrations and post market compliance, working closely with healthcare regulatory bodies globally
  • Develops global regulatory strategies, including execution of the regulatory product registrations to support global new product introduction launches. Works closely with cross-functional teams like engineering and product management to drive solutions.
  • Assesses changes in existing products and determines the need for new / revised licenses or registrations.
  • Reviews and approves advertising and promotional material to ensure consistency with approved claims and regulatory requirements.
  • Leads regulatory inspection support, as well as support for regulatory inquiries from authorities related to adverse events or recalls.
  • Developing specialized depth and/or breadth of expertise in own job discipline or field. Serves as best practice/quality resource. Has awareness of latest functional developments in own area. Contributes towards strategy and policy development, and ensures delivery within area of responsibility.
  • Skilled influencer, able to communicate complex messages to others. Acts as a resource for colleagues with less experience. May lead small projects with moderate risks and resource requirements. Explains difficult or sensitive information; works to build consensus. Developing persuasion skills required to influence others on topics within field.
  • Uses judgment to make decisions or solve moderately complex tasks or problems that impact the function. Takes new perspective on existing solutions. Uses technical experience and expertise for data analysis to support recommendations. Uses multiple internal and limited external sources outside of own function to arrive at decisions.


Required Qualifications
  • Bachelor's Degree in a Scientific or Engineering discipline (OR a minimum of 12 years work experience.)
  • A minimum of 8 years Regulatory Affairs / Quality Assurance experience
  • A minimum of 8 years experience in the medical device or pharmaceutical industry


Desired Characteristics
  • Strong oral and written communication skills.
  • Strong interpersonal and leadership skills.
  • Demonstrated ability to analyze and resolve problems.
  • Demonstrated ability to lead programs / projects.
  • Ability to document, plan, market, and execute programs.
  • Established project management skills.
  • Advanced degree in scientific, technology or regulatory affairs disciplines
  • Regulatory Affairs Certification (RAPS)


We will not sponsor individuals for employment visas, now or in the future, for this job opening.

Relocation Assistance Provided: No

About General Electric Company

GE Healthcare provides medical technology, intelligent devices, and care solutions. They offer medical imaging, information technologies, medical diagnostics, patient monitoring systems, performance improvement, drug discovery, and biopharmaceutical manufacturing technologies. GE Healthcare's mission is to improve patient care and outcomes by providing innovative healthcare solutions. Their technologies are used in hospitals, clinics, research institutions, and pharmaceutical companies worldwide to diagnose and treat various medical conditions.

General Electric Company Careers

Join the dynamic team at General Electric Company, a global leader in innovation and technology. As one of the most respected companies worldwide, we offer unparalleled job opportunities that propel your career to new heights. Work You’ll Do At General Electric Company, you’ll be part of a diverse team committed to transforming industries and improving lives through leadership in sectors such as aviation, power, renewable energy, and healthcare. Our culture thrives on innovation and leadership, fostering an environment where you can grow professionally and personally. Lead in a Unique Market Position General Electric Company stands at the forefront of digital and industrial transformation. Here, you’ll leverage your skills to solve complex challenges, drive growth, and lead projects that have a global impact. Our commitment to professional development and diversity training ensures that every team member is equipped to lead and innovate. Collaborate with Industry Experts Work alongside a global network of professionals, each bringing a wealth of knowledge and experience to our collaborative projects. General Electric Company’s culture of inclusivity and teamwork makes it a prime environment for networking and personal development. Innovative Work Join us to work on groundbreaking projects that redefine what’s possible. Our teams at General Electric Company are constantly pushing the boundaries of technology and innovation to create solutions that not only meet but exceed the needs of our customers and communities around the world. Be Part of a Great Team At General Electric Company, we understand that our employees are our greatest asset. That’s why we offer competitive benefits, extensive career advancement opportunities, and a supportive environment that values work-life balance. Our commitment to employee growth is reflected in our robust training programs and our focus on internal mobility. Future-Proof Your Career With a career at General Electric Company, your growth is limitless. Through our various training programs, internships, and leadership development initiatives, you can enhance your skills and advance your career in a direction that aligns with your professional and personal aspirations. Explore Job Opportunities and Internships Whether you’re starting your career or looking to make a significant impact in your field, General Electric Company offers a range of positions and employment opportunities that cater to your talents and ambitions. From internships that provide real-world experience to leadership roles that challenge your strategic thinking, there’s a place for you here. Stay Connected Join Our Team Search open positions that match your skills and interests. We are always on the lookout for passionate, curious, and solution-driven team players. Explore the possibilities that await you at General Electric Company. Keep Up to Date Stay informed with career tips, insider perspectives, and industry-leading insights—all from the people who work here. At General Electric Company, we’re more than a company—we’re a community. Job Alert Emails Customize your subscription to receive job alerts, the latest news, and insider tips tailored to your preferences. Discover the exciting and rewarding career opportunities available at General Electric Company and become part of a team that’s reshaping the future of technology and industry. Join General Electric Company today and be a part of our journey to build a better world through essential technology and innovative solutions. Your career at General Electric Company awaits—explore, innovate, and lead with us.
Learn more about General Electric Company
Size
168,000 employees
Market Cap
$90.4 billion
Industry
Net Income
$5.7 billion
Founded
1892
5 Year Trend
-9.1%
Revenue
$79.6 billion
NASDAQ

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