Regulatory Affairs Specialist

• 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