Manager, Regulatory Compliance

Overview

At Spacelabs Healthcare, you make a difference.

Every member of our worldwide team plays an integral role in improving treatment and helping providers deliver exceptional care to their patients. From newborns to centenarians, more than 60 million people benefit each year from the advancements we make in patient monitoring and management, care coordination and clinical decision

support.

Driven by the belief that anyone who seeks care could be a member of our own family, our team is dedicated to solving the greatest challenges the healthcare system currently faces, including the need to enhance the patient experience, improve population health, reduce costs, support care team well-being and advance health equity. As part of our mission, we take pride in creating services and technologies that are personalized and tailored to support the needs of healthcare providers anywhere in the world.

Because while we may not be at a patient’s bedside, their health is still in our hands.

The Manager, Regulatory Compliance is responsible for leading Spacelabs' regulatory compliance program, including maintaining QMS alignment with current regulations and standards, audit readiness, regulatory intelligence and standards monitoring, trade compliance, and cross-functional alignment with applicable regulations and standards. The role also contributes to Spacelabs post-market surveillance programs, focused on Field Corrective Actions (FCAs), product recalls, and safety reporting to global health authorities.

This highly visible people manager role oversees activities spanning regulatory intelligence and compliance, post-market surveillance, and field actions. The individual will lead and develop direct report(s), ensure compliant execution of regulatory and post-market processes, identify and address compliance gaps, and drive the safety and efficacy of Spacelabs products. The Manager, Regulatory Compliance develops and implements tools, training programs, and measurement systems to support product and process improvement.

This role requires an understanding of global regulatory obligations including MDSAP nations, the EU, UK, and other global markets, as well as applicable corporate compliance and trade compliance requirements.

***Preference will be given to local candidates but consideration will be given to non-local candidates that can work remotely.***

Responsibilities

• Lead, develop, and mentor direct report(s); set objectives, manage performance, and build team capability to meet current and future compliance needs.
• Support the Quality Management System (QMS) by ensuring it remains current with applicable regulations and standards (e.g., ISO 13485, 21 CFR Part 820, MDSAP, and EU MDR); partner with the Quality department to assess changes and update procedures and work instructions as needed.
• Own the regulatory intelligence and standards monitoring program; track new and revised regulations, guidance, and standards across global markets, assess business impact, and coordinate implementation of required changes.
• Lead corporate compliance activities, including compliance policies, training, and monitoring related to anti-bribery and anti-corruption requirements, including the U.S. Foreign Corrupt Practices Act (FCPA).
• Support trade compliance activities, including export control classification and licensing, import and customs requirements, and restricted party screening, in accordance with applicable U.S. and international regulations.
• Lead and manage all Field Corrective Actions (FCAs) end-to-end, including initiation, planning, execution, health authority notification, and close-out; own Corrections and Removal (806) reporting and all global equivalent communications.
• Serve as the primary point of contact with global health authorities (FDA, EU Competent Authorities, Health Canada, TGA, MHRA, and others) for all field safety corrective action communications, regulatory notifications, and Field Safety Notices.
• Facilitate Health Hazard Evaluations (HHEs) to drive risk-based decision making on product safety issues; ensure timely escalation of defects, safety conditions, and use-related issues affecting product performance.
• Support the Quality department with adverse event and vigilance reporting, including MDRs and global equivalents; ensure accurate and timely submission in accordance with local regulations.
• Partner with clinical and regulatory personnel to prepare, maintain, and submit Post Market Surveillance plans and reports; ensure regulatory records demonstrate ongoing compliance with ISO 13485, MDR (EU) 2017/745, and other applicable standards/regulations.
• Monitor and report product safety performance metrics (KPIs); identify trends, drive corrective improvements, and report findings to management with quantified objectives.
• Support regulatory audits and inspections, including notified body and MDSAP audits, representing regulatory compliance, FCA, and post-market surveillance activities.
• Serve as a regulatory compliance resource to peers and cross-functional teams; provide guidance on applicable medical device regulations, standards, and quality requirements to support informed decision-making across the business.
• Support the Quality Management System (QMS) by contributing to the development, maintenance, and continuous improvement of procedures and work instructions in compliance with applicable regulations and standards.
• Uphold the company’s core values of Integrity, Innovation, Accountability, and Teamwork.
• Demonstrate behavior consistent with the company’s Code of Ethics and Conduct. Ensure that direct report(s) are trained and evaluated on their knowledge and adherence to the company’s values, Code of Ethics and Conduct, and applicable compliance policies.
• It is the responsibility of every employee to report to their manager or a member of senior management any quality problems or defects in order for corrective action to be implemented and to avoid recurrence of the problem.
• Duties may be modified or assigned at any time to meet the needs of the business.

Qualifications

• Bachelor’s degree in life science or engineering discipline or additional equivalent experience.
• 2+ years of medical device experience.
• 8+ years of regulatory compliance experience, including demonstrated focus with global regulatory authority communications.
• 5+ years of demonstrated leadership of teams.
• Knowledge of FDA (21 CFR Part 803/806/820), EU MDR, CMDR, MHRA, TGA, and related ROW regulations governing quality systems, FSCAs, adverse event reporting, and recall requirements.
• Working knowledge of corporate compliance (e.g., anti-bribery and anti-corruption, including FCPA) and trade compliance (e.g., export controls, import and customs requirements) programs.
• Experience establishing or maintaining a regulatory intelligence and standards monitoring process preferred.
• Practical knowledge of risk management principles (ISO 14971) and comfortable conducting product risk review meetings with a cross functional team.
• Proficiency in data analysis, trending tools, and KPI/dashboard development; professional knowledge of statistical methods preferred.
• Strong technical written and verbal communication skills; ability to work effectively across all levels of a global organization and remain composed in urgent circumstances.
• Proficiency with Microsoft Office applications (Word, Excel, PowerPoint, Outlook).
• Project management experience is desired.
• Working knowledge of agentic AI and ability to leverage AI to support work obligations preferred.
• May be required to support business operations across multiple time zones, including participation in early morning, evening, or overnight meetings to meet business requirements.
• Less than 5% travel may be required.
• Ability to work in the U.S. without visa sponsorship now or in the future.

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Please review our benefits here: Life at OSI

Pay may range from $110,000 to $150,000 annually

The pay range above represents annual base salary only.  Final compensation will be determined based on factors such as your job level, geographic location, date of hire, experience, job-related knowledge and skills, and education in conjunction with market and business considerations.

Base salary is one component of your total rewards package.  You may be eligible for long-term incentives, potential discretionary bonuses, and the ability to purchase company stock at a discounted rate through the Employee Stock Purchase Program (ESPP).  OSI also offers comprehensive benefits including various options for health plans, access to 401(k) retirement plan, health savings account, disability insurance, life insurance, AD&D insurance, leave of absence programs and an array of voluntary benefits.  In addition, paid time off is offered to be used for vacation, holidays, bereavement, and jury duty.  Full-Time salaried employees are entitled to flexible time-off.

NOTICE TO THIRD PARTY AGENCIES

OSI Systems, Inc. and its subsidiaries (collectively “OSI”) does not accept unsolicited resumes from recruiters or employment agencies. If any person or entity, including a recruiter or agency, submits any information, including any resume or information regarding any potential candidate, without a signed agreement in place with OSI, OSI explicitly reserves the right to use such information, and pursue and/or hire such candidates, without any financial obligation to the person, recruiter or agency. Any unsolicited information or resumes, including those submitted directly to hiring managers, are considered and deemed to be the property of OSI.

Equal Opportunity Employer - Disability and Veteran

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Poster Link:

https://www.eeoc.gov/sites/default/files/2023-06/22-088_EEOC_KnowYourRights6.12ScreenRdr.pdf

OSI Systems, Inc. has three operating divisions: (a) Security, providing security and inspection systems, turnkey security screening solutions and related services; (b) Healthcare, providing patient monitoring, diagnostic cardiology and anesthesia systems; and (c) Optoelectronics and Manufacturing, providing specialized electronic components and electronic manufacturing services for original equipment manufacturers with applications in the defense, aerospace, medical and industrial markets, among others.