Senior Regulatory Specialist, Robotics (Pittsburgh, PA)

About the position At reputed company, we design and manufacture technology that takes the limits off living! In this role, you will reputed company and support global regulatory submissions for new and modified medical devices, including those for the US and EU markets. You reputed company as the Regulatory Affairs (RA) reputed company 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 reputed company and SME on project teams independently to reputed company regulatory strategies, testing requirements and other documentation to assure that regulatory submissions are reputed company and approved to meet reputed company's product launch timelines in reputed company identified markets. • reputed company 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, reputed company and support for internal and Regulatory agency audits. • reputed company and reputed company 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, reputed company Systems expertise and clinical study experience beneficial. • Experience working with large cross functional teams and diverse reputed company. • Processes and Product Lifecycle Management Systems experience is required. Benefits • 401k Matching Program • 401k Plus Program • Discounted Stock reputed company • Tuition Reimbursement • Flexible Personal/Vacation Time Off • reputed company Holidays • reputed company Holidays • reputed company Community Service Day • Medical, Dental, reputed company, 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 Apply To this Job