Regulatory Affairs Specialist
Danaher Corporation
Summary
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.
Job description
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+ years of 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
Requirements
- 2+ years of 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
- 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
Benefits
- Paid time off
- Medical, Dental & Vision
- 401(k)
- Bonus/incentive pay
Company overview
Danaher Corporation is a leading global science and technology innovator headquartered in Washington, D.C., specializing in biotechnology, life sciences, and diagnostics. Founded in 1984 by brothers Steven and Mitchell Rales, the company has evolved from its origins as a manufacturing conglomerate into a premier healthcare technology organization with approximately 63,000 employees worldwide. Danaher operates through three core divisions: biotechnology (28% of revenues), which develops products for therapeutic development; life sciences (31% of revenues), focused on disease identification, new therapies, and drug testing/manufacturing; and diagnostics (41% of revenues), providing instruments, consumables, and software for disease diagnosis. The company's portfolio includes renowned brands such as Beckman Coulter, Cytiva, Pall Corporation, Cepheid, Leica Microsystems, and Abcam, serving pharmaceutical companies, biotechnology firms, healthcare providers, and research institutions globally. Danaher is distinguished by its Danaher Business System (DBS), a continuous improvement methodology that drives innovation and operational excellence. With 2024 revenues of $23.9 billion, the company ranks 180th on the Fortune 500 and plays a critical role in advancing scientific research, improving diagnostic capabilities, and accelerating the development of life-saving therapies.