<p>With a passion for life</p> <p>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.</p> <p>Are you looking for an inspiring career? You just found it.</p> <p>Job title: Senior Regulatory Affairs Specialist</p> <p>Salary: $111,925 to $150,000</p> <p>Job Location: 45 Barbour Pond Drive, Wayne, NJ 07470</p> <p>Education: Bachelor's degree in Engineering or a related field.</p> <p>Job title: Senior Regulatory Affairs Specialist</p> <p>Salary: $111,925 to $150,000</p> <p>Job Location: 45 Barbour Pond Drive, Wayne, NJ 07470</p> <p>Education: Bachelor's degree in Engineering or a related field.</p> <p>Job duties: Responsible for activities which lead to and maintain regulatory approval to market medical devices. Assess device and labeling changes for regulatory implications. Develop and maintain positive relationships with U.S. FDA, EU Notified Body and global regulatory agencies through oral and written communications regarding pre-submission strategy/regulatory pathway development, testing requirements, clarification and follow-up of submissions under review. Develop and deliver presentations to global regulatory agencies.</p> <p>Requirements: 5 years of experience with Medical Device Regulatory Affairs. Requires skills and experience to include:</p> <ul> <li>Experience with ISO 13485, 21 CFR Part 820 FDA QSR (Quality System Regulation), ISO 14971, IEC 62366-1, IEC 60601 Series, IEC 62304 and ISO/TR 20416 standards that guide the design, manufacturing, and post-market surveillance of medical devices. </li><li>Proficiency in preparing regulatory submissions such as 510(k) (U.S.), CE Marking (EU), and PMA (Premarket Approval) submissions. </li><li>EU MDR (European Union Medical Device Regulation): Knowledge of the EU MDR 2017/745 regulations for medical devices. </li><li>Ability to create and review technical files, including design dossiers, risk management files and clinical evaluation reports (CER). </li><li>Global Regulatory Requirements: Familiarity with global standards for medical device regulation in markets such as Brazil (ANVISA), Canada (Health Canada), Japan (PMDA), China (NMPA), and others. </li><li>Knowledge of regulatory requirements for device labeling, including user manuals, packaging, and instructions for use (IFU) according to local regulations (e.g., FDA, EU, etc.). </li><li>Ability to conduct and manage internal and external audits and inspections, and experience with FDA inspections, ISO audits, and Notified Body assessments. </li><li>Ability to manage regulatory projects, timelines, and cross-functional teams to ensure timely submission and approval of medical devices. This involves coordination with R&D, manufacturing, quality assurance, and marketing teams. </li><li>Familiarity with regulatory affairs and submission management tools, regulatory submission tracking, and compliance management. </li></ul> <p>Standard employee benefits apply.</p>