Regulatory Affairs Specialist (Fully Remote)

Jobgether SRL; United States; Remote; USD 8,300 - 13,000; Full time

Benefits offered by this job

Healthcare coverage

Paid time off

Remote-friendly work

Job summary

Jobgether is seeking a Regulatory Affairs Specialist to secure regulatory approvals for innovative medical devices in India. You will work at the intersection of medical technology, compliance, and product innovation.

You will coordinate filings, prepare technical documentation, monitor Indian regulations, and communicate updates to global teams while collaborating across functions in a remote-friendly, internationally connected environment.

Qualifications

• Minimum 2 years of experience in Class II or III medical device environments.
• Strong understanding of Indian regulatory submissions and BIS certification.
• Excellent communication and organizational skills.

Responsibilities

• Coordinate domestic and international product filings, registrations, and regulatory submissions.
• Prepare technical documentation and maintain regulatory files for medical device approvals.
• Monitor changes in Indian regulations and communicate updates to global teams.

Skills

Experience with Class II/III medical</

Regulatory submissions (India BIS)

Communication skills

Organizational skills

Job description

• The Regulatory Affairs Specialist will secure regulatory approvals for innovative medical devices in India.
• This role works at the intersection of medical technology, compliance, and product innovation.

Key Responsibilities:

• Coordinate domestic and international product filings, registrations, and regulatory submissions.
• Prepare technical documentation and maintain regulatory files for medical device approvals.
• Monitor changes in Indian regulations and communicate updates to global teams.

Requirements:

• Minimum 2 years of experience in Class II or III medical device environments.
• Strong understanding of Indian regulatory submissions and BIS certification.
• Excellent communication and organizational skills.
• Healthcare coverage and paid time off.
• Remote work flexibility and international collaboration.
• Professional development opportunities in regulatory affairs.

Jobgether

The company develops innovative medical devices and operates in a global healthcare technology environment. It values regulatory compliance, cross-functional collaboration, and professional growth, with a remote-friendly and internationally connected culture.