Job Title:  Senior Manager, Regulatory Affairs

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. This role develops and executes regulatory strategies that support product development, market access, commercialization, and global business expansion while maintaining compliance with FDA, EU MDR, and other international regulatory requirements.

The Sr. Manager, Regulatory Affairs oversees global submissions, registrations, certifications, and post-market regulatory activities, including FDA 510(k) submissions, CE Marking, Medical Device Reporting (MDR), UDI/GUDID compliance, Software as a Medical Device (SaMD), cybersecurity requirements, field actions, regulatory reporting, and regulatory intelligence. This leader partners closely with Engineering, Product Management, Clinical, Quality, and Operations teams to ensure regulatory requirements are incorporated throughout the product lifecycle.

The successful candidate serves as a strategic advisor and subject matter expert on regulatory matters, drives continuous improvement initiatives, supports regulatory inspections and audits, and proactively identifies emerging regulatory trends and requirements that may impact Rauland products, processes, and business objectives.

The Sr. Manager, Regulatory Affairs demonstrates strong leadership skills, operates effectively in a cross-functional environment, and influences stakeholders at all levels of the organization. This role requires the ability to work independently, solve complex regulatory challenges, and drive organizational compliance excellence.

Major 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.

• Support the execution of the AMETEK/Rauland talent strategy, including employee development, succession planning, coaching, and performance management activities.

• Foster a culture of engagement, accountability, inclusion, continuous improvement, and regulatory excellence.

• Champion Rauland's Quality Policy and promote the principles of Customer Satisfaction, Regulatory Compliance, Continuous Improvement, and Team Engagement.

• Collaborate with distributors, suppliers, and business partners to strengthen regulatory compliance and quality performance throughout the value chain.

Education & Experience:

• Bachelor's degree in Engineering, Regulatory Affairs, Life Sciences, Quality, or related technical discipline required. Advanced degree preferred.
• Minimum 10 years of progressive Regulatory Affairs experience within the medical device industry.
• Minimum 5 years of leadership and people management experience.
• Demonstrated success leading FDA 510(k) submissions for Class I and Class II medical devices.
• Strong experience implementing EU MDR requirements and supporting global regulatory compliance activities.
• Demonstrated experience supporting software-based medical devices, connected healthcare technologies, cybersecurity requirements, and Software as a Medical Device (SaMD) regulatory frameworks.
• Experience supporting international market access and regulatory registrations across Europe, Asia, and South America.
• Experience working within electronic Quality Management Systems (eQMS), such as MasterControl, QT9, or similar platforms.
• Extensive knowledge of FDA QMSR (21 CFR Part 820), ISO 13485:2016, ISO 14971:2019, FDA Cybersecurity Guidance, EU MDR, and Medical Device Reporting requirements.
• Experience with Design Controls, Risk Management, and Product Lifecycle Management processes.
• Experience leading or supporting FDA inspections, notified body audits, customer audits, UL audits, and corporate quality assessments.
• Regulatory Affairs Certification (RAC), Internal Auditor Certification, Six Sigma, or related professional certifications preferred.
• Knowledge of Lean and Six Sigma methodologies.

Travel Requirements:

• Ability to travel domestically and internationally as required.
• Travel may vary based on business needs and is expected to range between 30% and 50%, including visits to customers, distributors, suppliers, regulatory agencies, industry conferences, and company locations.

AI Qualification:

• Demonstrated ability and willingness to leverage AI tools to improve productivity, decision-making, work quality, and operational effectiveness.
• Ability to identify appropriate AI use cases and critically evaluate AI-generated outputs to ensure accuracy, compliance, and business value.