Sr Regulatory Affairs Specialist

Masimo•Irvine, CA

4d•Onsite

About The Position

The Sr Regulatory Affairs Specialist is an accomplished regulatory professional responsible for leading regulatory initiatives and collaborating with Sales and Marketing teams to secure domestic and international regulatory clearances for Masimo products, aligning with business objectives. This role involves providing supported regulatory assessments of medical device regulations to ensure effective application of regulatory requirements for new products and maintain compliance with pre-market regulatory clearances.

Requirements

Minimum of 3 years of work experience in a medical device Class II/ III environment.
Expert level understanding of FDA or International Regulations.
Experience with FDA/GMP requirements for medical device.
Experience in Quality Systems per ISO 13485.
Ability to work in a Project Team Environment.
Must know regulatory submission requirements for FDA Class II medical devices, and equivalent classification requirements for international submission.
Computer Proficiency with MS Office (Word/Excel/Access/Outlook).
Excellent verbal and written communication skills.
Excellent prioritizing, organizational, and interpersonal skills.
Excellent documentation skills including record maintenance/ tracking and understanding of document traceability.
A detail-oriented individual, with a “can do” attitude, and the 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.
Experience in patient monitor systems, hospital-based products, software or electronic device products.
Experience with FDA/GMP requirements for medical device.
Experience in Quality Systems per ISO 13485.
Experience interacting with regulatory bodies, such as the Notified Body.

Nice To Haves

Experience leading and applying regulatory interpretations in the development of products.
Successful CE Mark of a Class II device.
Experience authoring and obtaining a 510(k) clearance.
Success in international and domestic product registrations.
Graduate degree preferred.

Responsibilities

Ownership of regulatory objectives in the management of international and domestic registrations of a product and/or country.
Drafting and compiling of 510(k) Premarket Notifications and other types of regulatory submissions.
Manage international and domestic filings/registrations.
Review and maintenance of Technical Documentation Summaries.
Document and review regulatory interpretations of regulations.
Active coordination with regional regulatory team members on product changes and regulatory notification/ approval requirements.
Take ownership of communications with regulatory team members to assist in filings and responses to inquiries from health authorities and notified bodies worldwide.
Compile and submit product list on Certificate of Foreign Government and Free Sale Certificates.
Review and maintain product listings and establishment registrations with FDA.
Maintain regulatory databases and summary reports to support management efforts to track and trend filing and registration requirements worldwide.
Interpret and train others to keep them up-to-date on international and domestic regulatory requirements.
Lead QA and Engineering in efforts to fulfill regulatory initiatives.
Represent RA department in project meetings and provide regulatory guidance.
Review and update RA quality system procedures as required (SQP/SOP’s).
Provide guidance to other departments on applicable regulations.
Review and approve document change orders.
Performs other duties or special projects as assigned.