New

Regulatory Affairs Specialist I

Getinge
life insurance, vision insurance, paid time off, long term disability, tuition reimbursement, 401(k)
United States, Massachusetts, Waltham
Apr 14, 2026
With a passion for life Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers - and to save more lives, we need team players, forward thinkers, and game changers. Are you looking for an inspiring career? You just found it. This role is open to US based candidates Compensation depending upon location Job Overview The Regulatory Affairs Specialist I will support global regulatory compliance activities for medical devices across Paragonix's product portfolio. This role will assist in preparing and maintaining regulatory submissions, coordinating documentation updates, and ensuring compliance with international and domestic regulatory requirements. The Specialist I will collaborate cross functionally to support sustaining engineering, quality systems, and product lifecycle activities while gaining foundational experience in global regulatory affairs. Job Responsibilities and Essential Duties International Registrations Lead preparation and maintenance of international registrations and renewals. Maintain Rimsys (regulatory management system) to ensure accuracy and completeness of registration and UDI records. Labeling Coordination Coordinate label updates and translation requests ensuring alignment with regulatory requirements. Sustaining Support Perform sustaining change assessments to evaluate regulatory impact of manufacturing, design, or documentation changes. Standards Monitoring Monitor changes in applicable standards and regulations and perform gap analyses as needed. Support tracking and communication of changes to cross functional teams Other Support various external or internal regulatory requests under guidance from senior regulatory staff. Assist in drafting and updating regulatory procedures, work instructions, and related documentation. Support regulatory quality objectives and continuous improvement. Required Qualifications Bachelor's degree in technical or scientific discipline; Master's degree or professional certification in Regulatory Affairs is a plus. Strong organizational and follow-up skills, as well as attention to detail Ability to work within a team and as an individual contributor in a fast-paced environment Ability to multitask, prioritize work, and meet deadlines in timely manner. Ability to work collaboratively across different departments. Excellent communication and interpersonal skills Excellent oral and written communication skills in English. Able to travel domestically and internationally as required (<10%) Able to work in the US without sponsorship now or any time in the future US BASED SALARY - The minimum base salary for this position is $65,000 and the maximum salary is $82,000 plus 5% in annual bonus. #LI-YA2 About us With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries. Benefits at Getinge: At Getinge, we offer a comprehensive benefits package, which includes: Health, Dental, and Vision insurance benefits 401k plan with company match Paid Time Off Wellness initiative & Health Assistance Resources Life Insurance Short and Long Term Disability Benefits Health and Dependent Care Flexible Spending Accounts Commuter Benefits Parental and Caregiver Leave Tuition Reimbursement Getinge is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, pregnancy, genetic information, national origin, disability, protected veteran status or any other characteristic protected by law.Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.