Quality Lead Specialist - Regulatory Affairs

Job Description Summary Job Description Summary This position is in GE Healthcare's MIM Software business which makes vendor-neutral imaging software to standardize your workflow and simplify increasingly complex clinical scenarios. Leading global healthcare organizations use MIM® to give patients more precise, personalized care. As Regulatory Affairs Specialist, you provide regulatory input and strategies to directly support development projects and marketed MIM Software products. The key responsibility is to develop and maintain the technical documentation throughout the entire life cycle of a product. Work with regional regulatory colleagues to obtain clearance in global markets. The role requires strong technical knowledge, good understanding of quality systems and global regulatory requirements. 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, 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. • Implementation of regulatory changes from around the world, including assessing the impact of the changes on existing products. • Reviews and approves advertising and promotion material to ensure consistency with approved claims and regulatory requirements. • Management of medical device shipments in accordance with regulatory approvals • Support for audits from various regulatory bodies. Qualifications/Requirements: • Bachelor's or Master degree in STEM fields or equivalent; • 2+ 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 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. • Experience in medical device regulatory affairs • Demonstrated life-long learner; eagerness to obtain new skills and knowledge. • *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.** We will not sponsor individuals for employment visas, now or in the future, for this job opening. For U.S. based positions only, the pay range for this position is $84,800.00-$127,200.00 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). Nonobstant le fait que GE HealthCare ne requiert actuellement pas des salariés américains (USA) qu'ils soient vaccinés contre la COVID-19, certains clients de GE HealthCare appliquent des règles de vaccination qui pourraient toucher certains salariés de GE HealthCare. Aide à la relocalisation fournie : Non Application Deadline: December 12, 2025 Apply tot his job