Job Description

HRS Navigation is aggressively expanding its business and further developing our team of talented professionals. You can We are actively seeking out the best and brightest to join our team. If you want to make a difference and join a team that is changing the surgical workplace then we want to hear from you!



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.
Be a part of something meaningful -- where Technology Meets Purpose and every day helps Save Lives.



Interested candidates, please send resume to: [email protected]