Director, Regulatory Affairs

Job Description Summary

This position provides strategic regulatory direction to the newly formed Peripheral Focused Ultrasound business regarding regulatory requirements for product launches and global submissions. You will be responsible for preparing regulatory strategies and premarket submissions, postmarket reporting/responses to regulator inquiries, regulatory intelligence, regulatory requirements flow-down and advertising / promotion, as applicable. Ensure compliance with all U.S. and international regulatory requirements pertaining to product approval. This position is an individual contributor with the potential to add resources as the business grows.

Job Description

Roles and Responsibilities

• Provides high quality regulatory advice and is seen as a valued strategic partner to the pFUS Business

• 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

• Researches, analyzes, integrates and organizes background information from diverse sources for regulatory submissions and strategic planning with leadership

• Works closely with Pharma partner to meet strategic imperatives for the pFUS product

• Provides deep domain expertise in regulatory areas critical to the Ultrasound business including Artificial Intelligence, medical software, biocompatibility, reprocessing, cybersecurity

• Prepares regulatory submissions (510(k), PMA, CE Technical Files) by working across the regulatory organization and cross functionally with other functions such as Engineering/R&D and submits premarket submissions to regulatory authorities, as per business timelines

• Reviews and approves advertising and promotion material to ensure consistency with approved claims and regulatory requirements.

• Impacts the team's ability to achieve timely regulatory submissions. Work is subject to regulatory policy objectives. Regularly advises management in the function and/or in the business. Has a supportive role in decision making about important subjects. High levels of evaluative judgment are required to achieve outcomes required.

• Uses high level of judgment to make decisions and handle complex tasks or problems that impact the regulatory. Has ability to assess quality of information given and ask pertinent questions to stakeholders. Able to offer new solutions to problems outside of set parameters and is able to construct and provide recommendations. Uses multiple internal and some external sources outside of own function to help arrive at a decision.

Required Qualifications

• Bachelor's Degree in a Scientific or Engineering discipline or a minimum of 10 years work experience in regulatory affairs for medical devices.

• Must have 6+ years Regulatory Affairs experience in preparing medical device submissions for US and EU markets, specifically Class III devices.

• Must have experience in interacting with the FDA, e.g. Pre-submission and/or submission meetings.

• Work requires willingness to work a flexible schedule.

• Legal authorization to work in the U.S. is required. We will not sponsor individuals for employment visas, now or in the future, for this job opening.

Desired Characteristics

• Degree in scientific, technology or regulatory affairs disciplines

• Regulatory Affairs Certification (RAPS) a plus

• Strong team leadership skills, facilitates teamwork, proven ability to lead and inspire

• Assertive and willing to make decisions and assign clear priorities and prioritize multiple competing priorities and complete tasks on time

• Ability to make sound business judgments both with independence and knowing when to seek advice and support

• Excellent verbal and written communication, presentation skills, including experience presenting at FDA meetings.

• Ability to communicate clearly, succinctly and effectively with various clients including Regulatory Agencies.

• Strong interpersonal skills and management experience a plus

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For U.S. based positions only, the pay range for this position is $144,000.00-$216,000.00 Annual. It is not typical for an individual to be hired at or near the top of the pay range and compensation decisions are dependent on the facts and circumstances of each case. The specific compensation offered to a candidate may be influenced by a variety of factors including skills, qualifications, experience and location. In addition, this position may also be eligible to earn performance based incentive compensation, which may include cash bonus(es) and/or long term incentives (LTI). GE HealthCare offers a competitive benefits package, including not but limited to medical, dental, vision, paid time off, a 401(k) plan with employee and company contribution opportunities, life, disability, and accident insurance, and tuition reimbursement.

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 COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees.

Relocation Assistance Provided: No

Application Deadline: June 14, 2024