Sr Regulatory Affairs Specialist

Masimo Corporation; Irvine, Northern (CA, KY); Hybrid; USD 85,000 - 130,000; Full time

Benefits offered by this job

Medical

Dental

Vision

Life/AD&D

401(k)

Vacation

Sick

Holiday

Paid Maternity Leave

Flexible Spending Accounts

Pet Insurance

On-site Wellness Clinic

Fitness Center

Café

Job summary

Masimo Corporation in Irvine, CA is seeking an Sr Regulatory Affairs Specialist to oversee international and domestic registrations and lead regulatory submissions for medical device products. The role interfaces with Sales, Marketing, QA, and Engineering to ensure pre-market clearances and ongoing compliance across regions.

The candidate should have 3+ years in a Class II/III medical device environment, strong FDA/International regulation knowledge, ISO 13485 experience, and proven ability to

Qualifications

• 3+ years of work experience in a medical device Class II/III environment
• Expert understanding of FDA or International Regulations
• Experience with FDA/GMP requirements for medical devices
• Experience in Quality Systems per ISO 13485
• Ability to work in a project team environment
• Regulatory submission requirements for FDA Class II devices and international submissions

Responsibilities

• Own regulatory objectives for international and domestic registrations
• Draft and compile 510(k) Premarket Notifications and other regulatory submissions
• Manage international and domestic filings/registrations
• Review and maintain Technical Documentation Summaries
• Interpret regulatory regulations and train others
• Coordinate with regional teams on product changes and regulatory requirements
• Lead communications with health authorities and notified bodies
• Review product listings and establishment registrations with FDA
• Maintain regulatory databases and trend filing requirements
• Provide regulatory guidance across departments
• Lead QA and Engineering to fulfill regulatory initiatives
• Represent RA in project meetings and QA procedures
• Review and approve document change orders
• Perform other duties and special projects as assigned

Skills

FDA/Regulatory knowledge

Regulatory submissions

ISO 13485 quality systems

Project team collaboration

MS Office proficiency

Education

Bachelor’s degree in Engineering, Life Sciences, or Regulatory

Tools

MS Office

Job description

Job Summary

Sr Regulatory Affairs Specialist is an accomplished regulatory professional with a successful work history with leading regulatory initiatives and partnering with Sales and Marketing teams in obtaining domestic and internal regulatory clearances for Masimo products to meet business objectives. The individual in this position 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.

Duties & 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.

Minimum & Preferred Qualifications and Experience:

Minimum Qualifications

• 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.

Preferred Qualifications

• 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.

Education

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

Compensation

The anticipated salary range for this position is $85,000 - $130,000 plus benefits. Actual placement within the range is dependent on multiple factors, including but not limited to skills, education, and experience. This position also qualifies for up to 10% annual bonus based on Company, department, and individual performance.

• Medical
• Dental
• Vision
• Life/AD&D
• Disability Insurance
• 401(k)
• Vacation
• Sick
• Holiday
• Paid Maternity Leave
• Flexible Spending Accounts
• voluntary Accident
• Critical Illness
• Hospital
• Long-Term Care
• Employee Assistance Program
• Pet Insurance
• on-site Wellness Clinic
• Fitness Center
• Café

All benefits are subject to eligibility requirements.

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 validDriver’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 accommodation may be made for those individuals with real or perceived disabilities to perform the essential functions of the job described.