Regulatory Affairs Specialist

Regulatory Affairs Specialist

The Regulatory Affairs Specialist will play a key role in securing regulatory approvals for innovative medical devices in the Indian market. This position offers the opportunity to work at the intersection of medical technology, regulatory compliance, and product innovation. You will collaborate with regional and global regulatory teams to support product registrations, submissions, and regulatory documentation. The role involves interpreting local regulatory requirements and assessing their impact on product development and commercialization. You will contribute to maintaining compliance with applicable Indian medical device regulations and import/export requirements. Working closely with cross-functional stakeholders, you will help ensure that regulatory processes are accurate, efficient, and aligned with business objectives. This is an excellent opportunity for a regulatory professional seeking to deepen their expertise in a dynamic, internationally connected healthcare technology environment.

Accountabilities

• Support regional regulatory affairs activities by coordinating domestic and international product filings, registrations, and regulatory submissions.
• Prepare, compile, and maintain technical documentation and regulatory files required for medical device approvals.
• Coordinate tender-related submissions and prepare responses to audit findings and regulatory inquiries.
• Monitor changes in Indian regulations and communicate relevant updates to global regulatory teams, including assessments of their potential impact on products and business operations.
• Collaborate with international regulatory representatives to facilitate submissions and respond to requests from health authorities.
• Maintain product listings and establishment registrations with the relevant Indian regulatory authorities.
• Serve as the regulatory affairs representative on project teams responsible for new product introductions and product modifications.
• Support compliance with applicable medical device regulations, import/export requirements, and Bureau of Indian Standards (BIS) certification processes.
• Contribute to continuous improvement in regulatory documentation, submission quality, and compliance processes.

Requirements

• A minimum of 2 years of professional experience in a Class II or Class III medical device environment.
• Demonstrated experience with Indian regulatory affairs requirements within the medical device industry.
• Working knowledge of import and export regulations for IT equipment and the BIS certification application process.
• Strong understanding of regulatory submissions, product registration procedures, and medical device compliance documentation.
• Excellent written and verbal communication skills, with the ability to collaborate effectively with regional, global, and cross-functional teams.
• Strong organizational skills, attention to detail, and the ability to manage multiple regulatory activities accurately.
• Ability to travel when required.

• Experience with patient monitoring systems, hospital-based products, software, or electronic medical devices.
• Knowledge of Indian regulatory submission requirements for Class II medical devices.
• Familiarity with quality management systems and ISO 13485 standards.
• Experience working with international regulatory teams in a global medical technology organization.

Benefits

• Competitive benefits package designed to support employees' health, financial well-being, and work-life balance.
• Healthcare coverage and other employee benefit programs, with specific offerings depending on location.
• Paid time off to support personal needs and well-being.
• Remote work flexibility, with the opportunity to work from home.
• International collaboration with regional and global regulatory professionals.
• Professional development opportunities in medical device regulations, product compliance, and healthcare technology.
• Meaningful impact, contributing to the regulatory approval of medical technologies that support clinicians and patient care.