job title: Regulatory affairs specialist(masimo)

Roles and Responsibilities

The primary role for the Regulatory Affairs Specialist is to manage end to end Regulatory Submissions & Compliance for Masimo India team

• Prepare, draft, and compile 510(k)/any other applicable Premarket Notifications and related FDA submissions.

• Support domestic and international product filings and registrations, including maintenance of EU Technical Files, Declarations of Conformity, and design dossiers.

• Maintain product listings for Certificates of Foreign Government and ensure documentation remains current and accurate.

• Stay updated on FDA, ISO, and international regulatory requirements; apply changes as needed to internal processes and documentation.

• Generate and maintain product compliance checklists and regulatory documentation.

• Review and approve document change orders (DCOs/Agile) as required.

Product Certification & Testing

• Coordinate with engineering and certified labs (UL/ETL) to obtain and maintain product safety and performance certifications.

• Work with internal engineers to define and meet test protocols and regulatory testing requirements.

• Provide subject matter expertise on IEC/ISO standards, including electrical safety, EMC, and software compliance.

Cross-Functional Support & Guidance

• Collaborate with international regulatory counterparts to assess regulatory impact of product changes and define required notifications or approvals.

• Provide regulatory support to OEM deployment activities and project teams.

• Participate in project meetings as the RA representative and offer strategic regulatory input.

• Assist QA and Engineering teams in preparing risk management documentation, such as FMEA and FTA.

• Contribute to the maintenance and update of RA quality system procedures (SOPs/SQPs).

• Performs other duties or special projects as assigned;

  • 3+ years of regulatory affairs experience in Class II or III medical device industry within Indian subcontinent.

Minimum & Preferred Qualifications and Experience:

Minimum Qualifications:

• In-depth knowledge of FDA regulations and GMP requirements.

• Experience with ISO 13485 Quality Management Systems strongly preferred

• Solid understanding of domestic and international submission requirements for medical devices.

• This is a fast paced, multi tasking role with clear deliverables with tight deadlines.

• Work closely with the sales / commercial team to understand the business critical priorities and deliver results

• Proficient in Microsoft Office Suite (Word, Excel, Outlook, Access).

• Strong written and verbal communication skills.

• Excellent organizational, prioritization, documentation, and multitasking abilities.

• Self-motivated with a detail-oriented mindset and ability to work independently or within a team.

• Comfortable working in a fast-paced, deadline-driven environment.

• Previous experience in Regulatory Submissions & Compliance is strongly preferred

Preferred Qualifications:

• Experience with patient monitoring systems, hospital-based medical products.

• Knowledge of UL/ETL certification processes.

• Experience interacting with notified bodies or international regulatory agencies.

Education:

BA/BS Degree, or equivalent combination of education and experience is required.

Physical requirements/Work Environment

This position primarily works in an office/home office environment. It requires frequent sitting, standing and walking. Daily use of a computer and other computing and digital devices is required.