Regulatory Affairs Specialist

Masimo Corporation; Irvine (CA); On-site; USD 80,000 - 100,000; Full time

Benefits offered by this job

Bonus & Incentives

Job summary

Masimo Corporation in Irvine, CA is seeking a Regulatory Affairs Specialist to obtain domestic and internal regulatory clearances for medical devices, ensuring compliance with FDA and ISO 13485 standards. This on-site role reports to the Director, Regulatory Affairs and involves coordinating filings (510(k)), communicating with regional authorities, and maintaining thorough documentation.

A Bachelor’s in Engineering or Life Sciences and 2+ years in Class II/III device environments are required,

Qualifications

• 2+ years of experience in a medical device Class II/III environment.
• Bachelor's degree in Engineering or Life Sciences is required.
• Excellent documentation and record-keeping skills.

Responsibilities

• Support filings such as 510(k) notifications, technical files, STED docs and related submissions.
• Coordinate with regional teams on product changes and regulatory requirements.
• Assist in communications with regional authorities for filings and inquiries.

Skills

Regulatory submissions

Regulatory communications

Documentation & traceability

Education

Bachelor's degree in Engineering or Life Sciences

Job description

Bring more to life.

Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?

At Masimo, one of Danaher's 15+ operating companies, our work saves lives-and we're all united by a shared commitment to innovate for tangible impact.

You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher's system of continuous improvement, you help turn ideas into impact - innovating at the speed of life.

Masimo is a global medical technology company that develops and produces a wide array of industry-leading monitoring technologies, including non-invasive measurements, sensors, patient monitors, and automation and connectivity solutions. Our mission is, Masimo innovations empower clinicians to transform patient care. When you join our team, you’ll be part of a culture that's driven by passion, challenging the status quo, and making an impact in the lives of others.

Learn about the Danaher Business System which makes everything possible.

The Regulatory Affairs Specialist is responsible for obtaining domestic and internal regulatory clearances for Masimo products to meet business objectives. The individual will be capable of providing supported regulatory assessments of medical device regulations to help effective application of regulatory requirements to future products to ensure compliance of the product to pre-market regulatory clearances.

This position reports to the Director, Regulatory Affairs and is part of the Regulatory Affairs team located in Irvine, CA and will be an on-site role.

In this role, you will have the opportunity to:

• Support the regulatory team managing international and domestic filings/registrations, including drafting and compiling of 510(k) Premarket Notifications, technical files, STED Documents and related submissions.
• Coordinate with regional regulatory team members on product changes and regulatory notification / approval requirements.
• Assist in communications with regional regulatory representatives to assist in filings and responses to inquiries from health authorities and notified bodies worldwide.

The essential requirements of the job include:

• 2+ yearsof work experience in a medical device Class II/ III environment.
• Bachelor's degree is required, preferably in Engineering or Life Sciences.
• Excellent documentation skills including record maintenance/ tracking and understand document traceability.

It would be a plus if you also possess previous experience in:

• Regulatory submission requirements for FDA Class II medical devices, and equivalent classification requirements for international submission.
• FDA/GMP requirements for medical device.
• Quality Systems per ISO 13485.
• Graduate Degree

Masimo, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it's a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info.

The annual salary range for this role is$80,000 - $100,000. This is the range that we in good faith believe is the range ofpossible compensationfor this role at the time of this posting. This range may bemodifiedin the future.

This job is also eligible for bonus/incentive pay.

We offercomprehensivepackage of benefits including paid time off, medical/dental/vision insurance and 401(k) to eligible employees.

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company's sole discretion, consistent with the law.

Bonus / Incentive Pay

10% of annual base salary

This job is also eligible for bonus / incentive pay.This is the target earnings as % of base annual salary, subject to objective eligibility criteria and performance conditions as set out in the applicable scheme terms and conditions.

This job is also eligible for a comprehensive package of benefits. Detailsregardingthese benefits will be provided separately.

Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.

The U.S. EEO posters are available here.

We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact:1-202-419-7762 or [e-mail].