Regulatory Affairs Specialist

Role: Regulatory Affairs Specialist
Experience: 3 To 5
Location: Bangalore

Minimum Education:
Bachelor’s degree in a scientific, engineering, or regulatory-related field (advanced degree preferred).

• 3–5 years of experience in regulatory affairs within the medical device industry.
• Experience with FDA regulations (21 CFR Part 820), EU MDR, ISO 13485, and international regulatory frameworks.
• Proven track record of preparing regulatory submissions (510(k), Technical Files, etc.).
• Start-up or small company experience highly desirable.
• Excellent written and verbal communication skills.
• Strong project management skills and ability to manage multiple priorities in a fast-paced environment.
• Detail-oriented, proactive, and adaptable.
• RAC (Regulatory Affairs Certification) or equivalent professional certification.
• Experience with Software as a Medical Device (SaMD) or digital health products.
• Prior experience leading or contributing to regulatory strategy for first-time product submissions. Familiarity with international regulatory pathways (e.g., TGA, NMPA, PMDA).
• Knowledge of clinical evaluation requirements under EU MDR.
• Familiarity with risk management per ISO 14971 and usability engineering per IEC 62366.
• Ability to thrive in an unstructured environment and contribute to the creation of scalable regulatory processes.

Skills Required:

• Develop and implement regulatory strategies to support product development and commercialization in target markets (e.g., India, US, EU, Canada).
• Prepare, submit, and manage regulatory submissions such as 510(k), CE marking under MDR, and Health Canada license applications.
• Interface with regulatory agencies, managing pre-submissions, responses to requests for information, and ongoing communications.
• Maintain current knowledge of regulatory requirements, guidance documents, and industry best practices and ensure timely compliance.
• Work cross-functionally with R&D, Clinical, Quality, and Marketing to ensure regulatory requirements are integrated throughout the product lifecycle.
• Review and develop product labels and assess promotional materials for compliance with relevant regulations and technical standards.
• Support creation and maintenance of the Technical Documentation/Design Dossier.
• Assist in the development and implementation of internal regulatory processes, SOPs, and best practices.
• Monitor and interpret regulatory changes that may impact products and provide strategic input accordingly.
• Evaluate incidents/complaints related to devices for medical device reporting obligations. Compile and submit reportable events to the appropriate regulatory bodies promptly.
• Support Quality Management System (QMS) activities, including audits, CAPAs, and compliance initiatives as needed.

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