Regulatory Affairs Specialist

Job Summary :

Regulatory Affairs Specialist is responsible for obtaining and documenting our mission-critical, domestic regulatory clearances for Masimo's amazing innovative products. The individual will be the sole RA representative on various project teams for new products. For each project, the individual will provide regulatory input on, for example, design, labelling, and clinical testing issues. Thus, the individual must work closely with Engineering and Marketing team members to understand the technology, marketing and clinical application of each new product.

As a team member on various projects proceeding in parallel and on different schedules, the individual must have excellent organizational and multitasking skills. During the project life cycle, the individual will be primarily responsible for preparing and filing 510(k) submissions by their deadlines. This preparation requires a detail-oriented, meticulous, and diligent approach. Moreover, the individual must take ownership of that 510(k) preparation and work with various Engineering, Marketing and other team members to finalize the submission. The individual will also perform research and analysis and providing guidance on other 510(k) related activities.

Duties & Responsibilities:

• 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;
• 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;
• Generate and maintain product compliance checklists;
• Provide regulatory support to the OEM Deployment group;
• Work with QA and Engineering in generating risk analysis, FMEA, and FTA reports;
• Submit document change orders (DRO/agile) for approvals;
• May represent RA department in project meetings and provide regulatory guidance;
• Update RA responsible quality system procedures as required (SQP/SOP's);
  Performs other duties or special projects as assigned;

Minimum & Preferred Qualifications and Experience:

Minimum Qualifications:

• A minimum of 2 years of work experience in a medical device Class II/ III environment;
• Working knowledge of FDA or international regulations.
• 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 understand document traceability;
• 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;

Preferred Qualifications:

• 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;
  Experience with UL/ETL certification process;
  Experience interacting with regulatory bodies, such as the Notified Body;

Education:

Bachelor's degree is required, preferably in Engineering or Life Sciences. Graduate degree preferred.

Physical requirements/Work Environment

This position primarily works in an office environment. It requires frequent sitting, standing and walking. Daily use of a computer and other computing and digital devices is required. May stand for extended periods when facilitating meetings or walking in the facilities. Some local travel is necessary, so the ability to operate a motor vehicle and maintain a valid Driver's license is required.

The physical demands of the position described herein are essential functions of the job and employees must be able to successfully perform these tasks for extended periods. Reasonable accommodations may be made for those individuals with real or perceived disabilities to perform the essential functions of the job described.

Masimo is proud to be an EOE/, M/F/D/V, and we are committed to Diversity at every level