Full-Time

Vice President

Regulatory Affairs

Posted on 9/18/2025

Masimo

Masimo

1,001-5,000 employees

Noninvasive patient monitoring devices and wearables

Compensation Overview

$222k - $277k/yr

+ 30% Annual Bonus

Irvine, CA, USA

Hybrid

International travel is required to meet with regulatory agencies, Notified Bodies, and internal teams.

Category
Legal & Compliance (1)
Required Skills
Risk Management
Requirements
  • Minimum 5 years in senior Regulatory Affairs leadership roles with direct responsibility for OUS regulatory activities.
  • Proven track record in obtaining and maintaining CE Mark approvals and other international market authorizations.
  • Expert knowledge of EU MDR/IVDR, ISO 13485, and major OUS market regulations.
  • Ability to work cross-functionally with engineering, clinical, manufacturing, marketing, and quality teams.
  • Strong negotiation and communication skills for engaging with regulatory authorities and Notified Bodies.
  • Demonstrated success operating in both structured multinational environments and fast-paced, entrepreneurial settings.
  • PC literate with exceptional organizational and recordkeeping skills.
Responsibilities
  • Lead the OUS Regulatory Affairs function in developing and implementing regional regulatory strategies, ensuring alignment with global business objectives.
  • Oversee all OUS regulatory submissions and approvals, including CE Mark applications, Technical File maintenance, device registrations, and renewals in targeted international markets.
  • Maintain up-to-date knowledge of regulatory requirements and guidance across key markets (e.g., EU MDR/IVDR, Health Canada, TGA, PMDA, CFDA/NMPA, LATAM, Middle East, Africa, and Asia-Pacific jurisdictions).
  • Represent Masimo in interactions with Notified Bodies, Competent Authorities, and other OUS regulatory agencies.
  • Provide guidance to product development teams on global design control requirements, risk management, and applicable international standards (ISO 13485, ISO 14971, IEC 60601, etc.).
  • Review and approve promotional, advertising, and labeling materials to ensure compliance with OUS regulations.
  • Support post-market surveillance and vigilance reporting requirements in OUS jurisdictions.
  • Develop, manage, and track departmental budget and resource allocation.
  • Recruit, develop, and mentor OUS regulatory team members, fostering high performance and compliance excellence.
  • Ensure regulatory intelligence systems are in place to monitor, assess, and communicate changes in international regulations to relevant stakeholders.
Desired Qualifications
  • Bachelor’s degree in life sciences, engineering, medicine, or a related field (advanced degree preferred).

Masimo is a global medical technology company that develops, manufactures, and markets noninvasive patient monitoring technologies for the healthcare sector. Its core offerings include the Root patient monitoring and connectivity platform and the Masimo W1 health-tracking wearable with FDA-cleared modules, reflecting a focus on noninvasive monitoring and consumer health wearables. The company expanded into consumer electronics by acquiring Sound United, enabling products that deliver personalized, lossless sound alongside health data capabilities. Its goal is to improve life by enhancing patient monitoring and delivering high-quality sound experiences, bridging healthcare with everyday health and wellness.

Company Size

1,001-5,000

Company Stage

IPO

Headquarters

Neuchâtel, Switzerland

Founded

1989

Simplify Jobs

Simplify's Take

What believers are saying

  • Q3 2025 revenues hit $371.2M, up 8.1% year-over-year.
  • $634M Apple patent win in November 2025 bolsters IP value.
  • Sold Sound United to Harman for $350M on May 7, 2025.

What critics are saying

  • FTC blocks Danaher $9.9B acquisition in H2 2026 over antitrust.
  • U.S. Customs bans Masimo W1 wearables imports in 3-6 months.
  • Tariffs hike pulse oximetry margins 5-10% in 6-12 months.

What makes Masimo unique

  • Masimo SET pulse oximetry excels in motion-tolerant blood oxygen monitoring.
  • Root platform integrates advanced patient monitoring and connectivity.
  • Rainbow Pulse CO-Oximetry measures multiple blood constituents noninvasively.

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Benefits

Health Insurance

Dental Insurance

Vision Insurance

Life Insurance

Disability Insurance

401(k) Retirement Plan

401(k) Company Match

Paid Vacation

Paid Sick Leave

Paid Holidays

Paid Maternity Leave

Health Savings Account/Flexible Spending Account

Flexible Work Hours

Pet Insurance

Wellness Program

Gym Membership

Company News

DelMorgan & Co.
Mar 25th, 2026
Danaher to acquire Masimo Corporation in $9.9Bn all-cash transaction.

Danaher to acquire Masimo Corporation in $9.9Bn all-cash transaction. Mar 25, 2026 On February 17, 2026, Danaher Corporation announced an agreement to acquire Masimo Corporation in an all-cash transaction valued at approximately $9.9Bn, or $180.00 per share. The transaction may reflect a broader consolidation trend taking shape across the acute care diagnostics sector - one in which large, diversified life science platforms are increasingly seeking to bring patient monitoring and telehealth-adjacent technology in-house rather than address these capabilities through partnerships alone. The transaction is anticipated to close in the second half of 2026, subject to customary regulatory approvals. Strategic reasoning. Danaher is a Washington, D.C.-based science and technology conglomerate with operations spanning life sciences and diagnostics, designing and manufacturing instruments, software and consumables used across research, healthcare and industrial applications. Danaher generated approximately $24.6Bn in total revenue in 2025. Central to its acquisition strategy is the Danaher Business System (DBS) - a lean management framework derived from the Toyota Production System that Danaher applies across every business it acquires to drive operational efficiency and performance improvement. Masimo is a leading developer of patient monitoring technology used widely in hospital and acute care settings, best known for its Signal Extraction Technology (SET) pulse oximetry system, which measures blood oxygen saturation and heart rate. For Danaher, the acquisition of Masimo is expected to expand a diagnostics segment that generated approximately $10.0Bn in revenue in 2025 out of total annual revenues of roughly $24.6Bn. Masimo is anticipated to operate as a standalone business unit and brand within Danaher's diagnostics division, maintaining its existing identity and product architecture while gaining access to Danaher's global commercial infrastructure and its proprietary operating framework, the Danaher Business System. This structure may allow Masimo to preserve the operational independence that has historically underpinned its product development capabilities, while potentially benefiting from Danaher's scale across international markets. The transaction may also accelerate Danaher's broader ambitions in the telehealth space. Masimo's monitoring technology has applications not only in traditional inpatient acute care settings but in remote and ambulatory care environments - a market that has seen sustained investment and growth in recent years. Masimo's healthcare revenue (which is understood to include a veterinary segment alongside its core hospital business) is estimated to have grown at approximately 9% in the period leading up to the announcement, suggesting continued underlying demand for its core products. The global market for pulse oximetry systems is projected to reach an estimated $2.1Bn by 2034, a trajectory that may reinforce the long-term strategic rationale for the deal. Market context. Masimo enters this transaction following a period of significant operational and governance disruption. The company faced sustained shareholder pressure stemming from its $1Bn acquisition of consumer audio brand Sound United in 2022 - a move widely viewed as a departure from Masimo's core healthcare mission that drew a high-profile activist campaign led by New York-based Politan Capital. The fallout from that campaign ultimately contributed to the departure of Masimo's founder and longtime CEO, Joe Kiani, a development that may have prompted the company to sharpen its focus on its core medical device business in the period that followed. More recently, Masimo prevailed in a patent infringement dispute against Apple related to blood oxygen monitoring technology incorporated into consumer wearables, with a California court awarding Massimo $634MM in damages in November 2025. That outcome may have meaningfully clarified the value and defensibility of Masimo's core intellectual property portfolio in the months preceding this transaction and may have contributed to the strategic confidence with which Danaher ultimately approached the acquisition. The resolution of any remaining related proceedings - including matters that may involve the U.S. Customs and Border Protection agency - could continue to bear on Masimo's business in the near term. Offer price and market response. The offer price of $180.00 per share represents a premium of approximately 38% to Masimo's pre-announcement trading price of approximately $130.15. Masimo's shares rose over 34% on the day of the announcement, reaching approximately $175.00 per share at market open on February 17, 2026. Industry implications. Should the transaction close as anticipated, it may signal increased appetite among diversified life science and diagnostics platforms for acquisitions in the acute care monitoring space - particularly as healthcare systems continue to face pressure to improve patient outcomes while managing cost. Masimo's position at the intersection of hospital infrastructure, proprietary signal processing and an emerging remote monitoring market could make the combined business a more competitive participant in what may be a rapidly evolving care delivery landscape. The deal could also reflect a broader pattern of consolidation in which large platform acquirers seek to bring differentiated, IP-backed medical technology in-house ahead of what may be an accelerating shift toward data-driven and continuous patient monitoring across both acute and ambulatory settings. The extent to which Danaher is able to leverage Masimo's brand and technology into adjacent segments will likely depend on integration timelines and the pace of commercial execution following close - factors that may take several years to assess with confidence. About DelMorgan & co. (www.delmorganco.com). With over $300 billion of successful transactions in over 80 countries, DelMorgan's Investment Banking professionals have worked on some of the most challenging, most rewarding and highest profile transactions in the U.S. and around the globe. DelMorgan specializes in capital raising and M&A advisor services for companies across all industries and is recognized as one of the leading investment banking practices in California and globally.

Yahoo Finance
Mar 22nd, 2026
Bridger Management exits $7M Masimo stake weeks before $9.9B acquisition sends shares up 34%

Bridger Management sold its entire stake in Masimo worth $7.06 million in February 2026, according to an SEC filing. The fund liquidated 47,841 shares before the stock surged 34% following a $9.9 billion acquisition announcement at $180 per share. The exit came after Masimo's shares dropped 12% following a weak quarter. Weeks later, the acquisition deal was announced, highlighting the risks of selling during temporary weakness. Masimo develops noninvasive patient monitoring technologies including pulse oximetry and brain function monitoring. The company serves hospitals, emergency services and healthcare providers globally, though it reported a net loss of $207.7 million on $1.5 billion revenue. Bridger Management's top holdings include Morgan Stanley at 15.6% of assets under management and Amazon at 9.8%.

Bitget
Mar 15th, 2026
Parkman Healthcare Partners buys $26M stake in Masimo ahead of $9.9B acquisition

Parkman Healthcare Partners has acquired a $26 million stake in Masimo Corporation, purchasing 200,000 shares during the fourth quarter of 2025. The position represents 2.48% of the fund's $1.05 billion in reported US equity assets. Masimo's shares have surged 35% this year following last month's announcement of a $9.9 billion acquisition agreement. The medical technology company, which specialises in noninvasive patient monitoring solutions, will be acquired for $180 per share in cash. The deal is expected to close in the second half of 2026. The investment joins Parkman's other major healthcare holdings, including Boston Scientific, Dexcom, Insulet and Stryker. Masimo's stock traded at $174.69 as of the most recent Friday, up 6% over the past year.

Yahoo Finance
Mar 15th, 2026
Parkman Healthcare Partners builds $26M stake in Masimo before $9.9B acquisition deal

Parkman Healthcare Partners disclosed a new $26 million stake in Masimo Corporation, purchasing 200,000 shares in the fourth quarter of 2025. The position represents 2.48% of the fund's $1.05 billion in US equity assets. Masimo shares have surged 35% this year following last month's announcement that the medical technology company agreed to be acquired for $180 per share in a $9.9 billion cash transaction. The deal, expected to close in the second half of 2026, will bring the patient monitoring specialist into a major diagnostics platform whilst maintaining its standalone brand. The stake sits alongside Parkman's holdings in Boston Scientific, Dexcom, Insulet and Stryker, reflecting a strategy focused on healthcare companies with strong intellectual property and durable hospital demand. Masimo specialises in noninvasive patient monitoring technologies.

Yahoo Finance
Mar 13th, 2026
Masimo beats Q3 revenue expectations with $371.2M, up 8.1% year-on-year

Masimo, a patient monitoring technology company, reported third-quarter revenues of $371.2 million, up 8.1% year on year and exceeding analysts' expectations by 1.3%. The company beat full-year earnings per share and operating income guidance estimates. The strong performance was driven by growth in Masimo's core healthcare business and operating efficiency initiatives. Operating margin improved by 450 basis points and earnings per share grew 38%. During the quarter, Masimo sold Sound United to Harman and used proceeds for share buybacks. The company also announced an expanded strategic partnership with Philips. Founded in 1989, Masimo develops noninvasive patient monitoring technologies, including pulse oximetry systems. The company plans to share more details on its strategy at an investor day on 3 December.

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