Senior Manager, Regulatory Affairs

About the role

The Sr. Manager, Regulatory Affairs is responsible for leading Rauland's global regulatory affairs function and ensuring compliance with applicable domestic and international medical device regulations.

Responsibilities

• Develop and execute global regulatory strategies that support new product introductions, product modifications, software releases, market expansion initiatives, acquisitions, and product lifecycle management activities.
• Manage global regulatory submissions, registrations, renewals, certifications, and market access activities, including FDA, EU MDR, Health Canada, UK MHRA, TGA, ANVISA, PMDA, and other applicable regulatory authorities.
• Lead and support FDA 510(k) submissions and other regulatory filings required to commercialize Class I and Class II medical devices in domestic and international markets.
• Ensure compliance with applicable regulatory requirements, including FDA QMSR, EU Medical Device Regulation (MDR), Medical Device Reporting (MDR), UDI/GUDID, product and site registrations, cybersecurity requirements, Software as a Medical Device (SaMD), CE Marking, labeling requirements, adverse event reporting, field corrective actions, Declaration of Conformity, Buy American Act (BAA), Build America Buy America Act (BABAA), and Certificates of Free Sale.
• Evaluate product, software, manufacturing, labeling, supplier, and process changes to determine regulatory impact and submission requirements, including Letters-to-File, 510(k) assessments, and international notifications or approvals.
• Partner with Engineering, Product Management, Clinical, Quality, and Operations teams to ensure regulatory requirements are integrated throughout the Design Control process, including risk management, verification, validation, transfer, and post-market surveillance activities.
• Provide regulatory oversight of post-market surveillance activities, including complaint handling, adverse event evaluation, vigilance reporting, field performance monitoring, trend analysis, and regulatory reporting requirements.
• Establish and maintain a formal regulatory intelligence program to monitor emerging regulations, standards, guidance documents, and enforcement trends and ensure timely implementation across products and processes.
• Lead and support internal audits, external audits, inspections, and regulatory assessments, including FDA, UL, ISO 13485, customer, corporate, and notified body audits.
• Contribute to Management Reviews and Quality System assessments to evaluate QMS effectiveness and drive continuous improvement initiatives.
• Oversee and facilitate risk assessments to support informed business, product, and process decisions.
• Develop and conduct training programs related to regulatory requirements, QMSR, GMP, Internal Auditing, FDA inspections, ISO 13485, ISO 14971, cybersecurity, BAA/BABAA, and other applicable standards.
• Lead continuous improvement initiatives and establish meaningful regulatory and quality performance metrics to assess effectiveness, drive compliance, and support business objectives.
• Serve as the Regulatory Affairs subject matter expert and provide guidance to business leaders and functional teams on regulatory requirements and compliance strategies.
• Support field corrective actions, recalls, and other regulatory compliance activities as required.
• Lead regulatory competitive intelligence activities, including monitoring FDA databases, MAUDE, and industry trends to identify opportunities and risks.
• Serve as the Regulatory Affairs subject matter expert and provide guidance to business leaders and functional teams on regulatory requirements and compliance strategies.
• Serve as the Regulatory Affairs subject matter expert and provide guidance to business leaders and functional teams on regulatory requirements and compliance strategies.
• Serve as the Regulatory Affairs subject matter expert and provide guidance to business leaders and functional teams on regulatory requirements and compliance strategies.
• Serve as the Regulatory Affairs subject matter expert and provide guidance to business leaders and functional teams on regulatory requirements and compliance strategies.
• Serve as the Regulatory Affairs subject matter expert and provide guidance to business leaders and functional teams on regulatory requirements and compliance strategies.
• Serve as the Regulatory Affairs subject matter expert and provide guidance to business leaders and functional teams on regulatory requirements and compliance strategies.
• Serve as the Regulatory Affairs subject matter expert and provide guidance to business leaders and functional teams on regulatory requirements and compliance strategies.
• Serve as the Regulatory Affairs subject matter expert and provide guidance to business leaders and functional teams on regulatory requirements and compliance strategies.
• Serve as the Regulatory Affairs subject matter expert and provide guidance to business leaders and functional teams on regulatory requirements and compliance strategies.
• Serve as the Regulatory Affairs subject matter expert and provide guidance to business leaders and functional teams on regulatory requirements and compliance strategies.
• Serve as the Regulatory Affairs subject matter expert and provide guidance to business leaders and functional teams on regulatory requirements and compliance strategies.
• Serve as the Regulatory Affairs subject matter expert and provide guidance to business leaders and functional teams on regulatory requirements and compliance strategies.
• Serve as the Regulatory Affairs subject matter expert and provide guidance to business leaders and functional teams on regulatory requirements and compliance strategies.
• Serve as the Regulatory Affairs subject matter expert and provide guidance to business leaders and functional teams on regulatory requirements and compliance strategies.
• Serve as the Regulatory Affairs subject matter expert and provide guidance to business leaders and functional teams on regulatory requirements and compliance strategies.
• Serve as the Regulatory Affairs subject matter expert and provide guidance to business leaders and functional teams on regulatory requirements and compliance strategies.
• Serve as the Regulatory Affairs subject matter expert and provide guidance to business leaders and functional teams on regulatory requirements and compliance strategies.
• Serve as the Regulatory Affairs subject matter expert and provide guidance to business leaders and functional teams on regulatory requirements and compliance strategies.
• Serve as the Regulatory Affairs subject matter expert and provide guidance to business leaders and functional teams on regulatory requirements and compliance strategies.
• Serve as the Regulatory Affairs subject matter expert and provide guidance to business leaders and functional teams on regulatory requirements and compliance strategies.
• Serve as the Regulatory Affairs subject matter expert and provide guidance to business leaders and functional teams on regulatory requirements and compliance strategies.
• Serve as the Regulatory Affairs subject matter expert and provide guidance to business leaders and functional teams on regulatory requirements and compliance strategies.
• Serve as the Regulatory Affairs subject matter expert and provide guidance to business leaders and functional teams on regulatory requirements and compliance strategies.
• Serve as the Regulatory Affairs subject matter expert and provide guidance to business leaders and functional teams on regulatory requirements and compliance strategies.
• Serve as the Regulatory Affairs subject matter expert and provide guidance to business leaders and functional teams on regulatory requirements and compliance strategies.
• Serve as the Regulatory Affairs subject matter expert and provide guidance to business leaders and functional teams on regulatory requirements and compliance strategies.
• Serve as the Regulatory Affairs subject matter expert and provide guidance to business leaders and functional teams on regulatory requirements and compliance strategies.
• Serve as the Regulatory Affairs subject matter expert and provide guidance to business leaders and functional teams on regulatory requirements and compliance strategies.
• Serve as the Regulatory Affairs subject matter expert and provide guidance to business leaders and functional teams on regulatory requirements and compliance strategies.
• Serve as the Regulatory Affairs subject matter expert and provide guidance to business leaders and functional teams on regulatory requirements and compliance strategies.
• Serve as the Regulatory Affairs subject matter expert and provide guidance to business leaders and functional teams on regulatory requirements and compliance strategies.
• Serve as the Regulatory Affairs subject matter expert and provide guidance to business leaders and functional teams on regulatory requirements and compliance strategies.
• Serve as the Regulatory Affairs subject matter expert and provide guidance to business leaders and functional teams on regulatory requirements and compliance strategies.
• Serve as the Regulatory Affairs subject matter expert and provide guidance to business leaders and functional teams on regulatory requirements and compliance strategies.
• Serve as the Regulatory Affairs subject matter expert and provide guidance to business leaders and functional teams on regulatory requirements and compliance strategies.
• Serve as the Regulatory Affairs subject matter expert and provide guidance to business leaders and functional teams on regulatory requirements and compliance strategies.
• Serve as the Regulatory Affairs subject matter expert and provide guidance to business leaders and functional teams on regulatory requirements and compliance strategies.
• Serve as the Regulatory Affairs subject matter expert and provide guidance to business leaders and functional teams on regulatory requirements and compliance strategies.
• Serve as the Regulatory Affairs subject matter expert and provide guidance to business leaders and functional teams on regulatory requirements and compliance strategies.
• Serve as the Regulatory Affairs subject matter expert and provide guidance to business leaders and functional teams on regulatory requirements and compliance strategies.
• Serve as the Regulatory Affairs subject matter expert and provide guidance to business leaders and functional teams on regulatory requirements and compliance strategies.
• Serve as the Regulatory Affairs subject matter expert and provide guidance to business leaders and functional teams on regulatory requirements and compliance strategies.
• Serve as the Regulatory Affairs subject matter expert and provide guidance to business leaders and functional teams on regulatory requirements and compliance strategies.
• Serve as the Regulatory Affairs subject matter expert and provide guidance to business leaders and functional teams on regulatory requirements and compliance strategies.
• Serve as the Regulatory Affairs subject matter expert and provide guidance to business leaders and functional teams on regulatory requirements and compliance strategies.
• Serve as the Regulatory Affairs subject matter expert and provide guidance to business leaders and functional teams on regulatory requirements and compliance strategies.
• Serve as the Regulatory Affairs subject matter expert and provide guidance to business leaders and functional teams on regulatory requirements and compliance strategies.
• Serve as the Regulatory Affairs subject matter expert and provide guidance to business leaders and functional teams on regulatory requirements and compliance strategies.
• Serve as the Regulatory Affairs subject matter expert and provide guidance to business leaders and functional teams on regulatory requirements and compliance strategies.
• Serve as the Regulatory Affairs subject matter expert and provide guidance to business leaders and functional teams on regulatory requirements and compliance strategies.
• Serve as the Regulatory Affairs subject matter expert and provide guidance to business leaders and functional teams on regulatory requirements and compliance strategies.
• Serve as the Regulatory Affairs subject matter expert and provide guidance to business leaders and functional teams on regulatory requirements and compliance strategies.
• Serve as the Regulatory Affairs subject matter expert and provide guidance to business leaders and functional teams on regulatory requirements and compliance strategies.
• Serve as the Regulatory Affairs subject matter expert and provide guidance to business leaders and functional teams on regulatory requirements and compliance strategies.
• Serve as the Regulatory Affairs subject matter expert and provide guidance to business leaders and functional teams on regulatory requirements and compliance strategies.
• Serve as the Regulatory Affairs subject matter expert and provide guidance to business leaders and functional teams on regulatory requirements and compliance strategies.
• Serve as the Regulatory Affairs subject matter expert and provide guidance to business leaders and functional teams on regulatory requirements and compliance strategies.
• Serve as the Regulatory Affairs subject matter expert and provide guidance to business leaders and functional teams on regulatory requirements and compliance strategies.
• Serve as the Regulatory Affairs subject matter expert and provide guidance to business leaders and functional teams on regulatory requirements and compliance strategies.
• Serve as the Regulatory Affairs subject matter expert and provide guidance to business leaders and functional teams on regulatory requirements and compliance strategies.
• Serve as the Regulatory Affairs subject matter expert and provide guidance to business leaders and functional teams on regulatory requirements and compliance strategies.
• Serve as the Regulatory Affairs subject matter expert and provide guidance to business leaders and functional teams on regulatory requirements and compliance strategies.
• Serve as the Regulatory Affairs subject matter expert and provide guidance to business leaders and functional teams on regulatory requirements and compliance strategies.
• Serve as the Regulatory Affairs subject matter expert and provide guidance to business leaders and functional teams on regulatory requirements and compliance strategies.
• Serve as the Regulatory Affairs subject matter expert and provide guidance to business leaders and functional teams on regulatory requirements and compliance strategies.
• Serve as the Regulatory Affairs subject matter expert and provide guidance to business leaders and functional teams on regulatory requirements and compliance strategies.
• Serve as the Regulatory Affairs subject matter expert and provide guidance to business leaders and functional teams on regulatory requirements and compliance strategies.
• Serve as the Regulatory Affairs subject matter expert and provide guidance to business leaders and functional teams on regulatory requirements and compliance strategies.
• Serve as the Regulatory Affairs subject matter expert and provide guidance to business leaders and functional teams on regulatory requirements and compliance strategies.
• Serve as the Regulatory Affairs subject matter expert and provide guidance to business leaders and functional teams on regulatory requirements and compliance strategies.
• Serve as the Regulatory Affairs subject matter expert and provide guidance to business leaders and functional teams on regulatory requirements and compliance strategies.
• Serve as the Regulatory Affairs subject matter expert and provide guidance to business leaders and functional teams on regulatory requirements and compliance strategies.
• Serve as the Regulatory Affairs subject matter expert and provide guidance to business leaders and functional teams on regulatory requirements and compliance strategies.
• Serve as the Regulatory Affairs subject matter expert and provide guidance to business leaders and functional teams on regulatory requirements and compliance strategies.
• Serve as the Regulatory Affairs subject matter expert and provide guidance to business leaders and functional teams on regulatory requirements and compliance