<p>• Thorough knowledge and understanding of US and International Medical Device Regulations, including MDSAP, with direct experience in US 510(k) and EU Class II devices.</p><p>• Strong knowledge of Quality Systems (Measurement, Analysis, and Improvement; Adverse Event and Advisory Reporting; Purchasing; Design and Development; Production and Service Controls, etc.)</p><p>• Expert working knowledge of regulatory requirements, standards, and regulations with significant audit experience.</p><p>• Strong communication, project management and influencing skills.</p><p>• Experience in compliance risk situations.</p><p>• Experience in technical writing and procedure development.</p><p>• Computer literacy.</p>

<p>• Ability to plan, organize, and implement multiple concurrent tasks.</p><p>• Strong interpersonal skills, written, oral communication and negotiations skills.</p><p>• Must demonstrate the ability to effectively communicate up/down and across different levels of the organization.</p><p>• Analytical and problem-solving capabilities with the ability to draw insights from data quickly and to define executable actions.</p><p>• Demonstrated ability to work in cross-functional team environments.</p><p>• Demonstrated ability to make timely and sound decisions through effective approaches for choosing a course of action or developing appropriate solutions.</p><p>• Act with a customer service/stakeholder-focused approach.</p><p>• Leverages excellent interpersonal keys to achieve desired outcomes.</p>

<p>Robert Half is the world’s first and largest specialized talent solutions firm that connects highly qualified job seekers to opportunities at great companies. We offer contract, temporary and permanent placement solutions for finance and accounting, technology, marketing and creative, legal, and administrative and customer support roles.</p> <p>Robert Half works to put you in the best position to succeed. We provide access to top jobs, competitive compensation and benefits, and free online training. Stay on top of every opportunity - whenever you choose - even on the go. <a href="https://www.roberthalf.com/us/en/mobile-app" target="_blank">Download the Robert Half app</a> and get 1-tap apply, notifications of AI-matched jobs, and much more.</p> <p>All applicants applying for U.S. job openings must be legally authorized to work in the United States. Benefits are available to contract/temporary professionals, including medical, vision, dental, and life and disability insurance. Hired contract/temporary professionals are also eligible to enroll in our company 401(k) plan. Visit <a href="https://roberthalf.gobenefits.net/" target="_blank">roberthalf.gobenefits.net</a> for more information.</p> <p>© 2025 Robert Half. An Equal Opportunity Employer. M/F/Disability/Veterans. By clicking “Apply Now,” you’re agreeing to <a href="https://www.roberthalf.com/us/en/terms">Robert Half’s Terms of Use</a>.</p>