Regulatory Affairs Specialist II

Masimo•Irvine, CA

8h•Hybrid

About The Position

Regulatory Affairs Specialist II is responsible for obtaining and documenting domestic and international regulatory clearances to support the marketing of Masimo products. The individual will be an RA representative on various project teams, providing expert guidance on regulatory requirements to cross-functional teams. For each project, the individual will provide regulatory input to support future regulatory submissions or to ensure compliance of the product to pre-market regulatory clearances. The individual will work closely with Engineering and Marketing team members to understand the technology, marketing and clinical application of each new product.

Requirements

A minimum of 2 years of work experience in a medical device Class II/ III environment.
Working knowledge of FDA or international regulations (e.g., EU MDR).
Computer Proficiency with MS Office (Word/Excel/Access/Outlook).
Excellent verbal and written communication skills.
Excellent prioritizing, organizational, multi-tasking, and interpersonal skills.
Excellent documentation skills including record maintenance/ tracking and understanding of technical documents.
A detail-oriented individual with a “can do” attitude and ability to work in a team environment as well as individually with minimal supervision.
Ability to work in a fast-paced environment, with multiple tasks/projects.
Ability to work in a Project Team Environment.
Experience in patient monitor systems, hospital-based products, software or electronic device products.
Knowledge of regulatory submission requirements for FDA Class II medical devices, and equivalent classification requirements for international submission.
Experience with FDA/GMP requirements for medical device.
Experience in Quality Systems per ISO 13485.

Nice To Haves

Experience interacting with regulatory bodies, such as the Notified Body.
Successful CE Mark of a Class II device.
Success in international and domestic product registrations.

Responsibilities

Support the international and domestic filings/registrations, including drafting and compiling of 510(k) Premarket Notifications, Technical Documentation Summaries, and other types of regulatory submissions.
Coordinate with regional regulatory team members on product changes and regulatory notification/ approval requirements.
Assist in communications with regulatory team members to assist in filings and responses to inquiries from health authorities and notified bodies worldwide.
Assist in compiling and submitting product list on Certificate of Foreign Government and Free Sale Certificates.
Assist in maintaining product listings and establishment registrations with FDA.
Assist in maintaining regulatory databases and summary reports to support management efforts to track and trend filing and registration requirements worldwide.
Maintain up-to-date knowledge on international and domestic regulatory requirements.
Submit and follow-up on document change orders (Agile) for approval.
Represent RA department in project meetings and provide regulatory guidance.
Performs other duties or special projects as assigned.