Senior Regulatory Specialist, Robotics (Pittsburgh, PA)
About the position At Smith+Nephew, we design and manufacture technology that takes the limits off living! In this role, you will lead and support global regulatory submissions for new and modified medical devices, including those for the US and EU markets. You act as the Regulatory Affairs (RA) lead and subject matter expert (SME) on cross-functional project teams, developing and executing regulatory strategies to meet product launch timelines and market expansion goals. Responsibilities • Work as the RA lead and SME on project teams independently to develop regulatory strategies, testing requirements and other documentation to assure that regulatory submissions are prepared and approved to meet the Company's product launch timelines in all identified markets. • Develop and implement global regulatory strategies and support product release for market expansion activities for new and modified products. • Maintain a working knowledge of global regulations, standards, guidance documents, country-specific requirements, medical devices and medical terminology. • Plan, lead and support for internal and Regulatory agency audits. • Lead and direct engagement with regulatory authorities as required. • Review and approve product labeling to ensure compliance with regulatory requirements. Requirements • Bachelor's degree required, preferably in a scientific or technical discipline. • RAPS Certification or RA Master's degree a plus. • 5+ years experience in Regulatory Affairs. • Experience with Class II devices. • Knowledge and practical application of medical device regulations (ISO, GMP, FDA, CE, EU MDR) and design controls. • Experience with internal/External Audits, Quality Systems expertise and clinical study experience beneficial. • Experience working with large cross functional teams and diverse groups. • Processes and Product Lifecycle Management Systems experience is required. Benefits • 401k Matching Program • 401k Plus Program • Discounted Stock Options • Tuition Reimbursement • Flexible Personal/Vacation Time Off • Paid Holidays • Flex Holidays • Paid Community Service Day • Medical, Dental, Vision, Health Savings Account (Employer Contribution of $500+ annually) • Employee Assistance Program • Parental Leave • Fertility and Adoption Assistance Program • Hybrid Work Model • Discounts on fitness clubs, travel and more! Apply tot his job