Job Description
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 Qualifications
Minimum & Preferred Qualifications and Experience:
- 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.
Masimo is proud to be an EOE/, M/F/D/V, and we are committed to Diversity at every level 
