Regulatory Affairs Specialist

Company Detail

Healthark Insights is a life sciences consulting firm established in 2016 by a team of consultants from top-tier strategy firms with a cumulative experience of 100+ years. Over the years, Healthark has developed a strong team of domain experts and consultants supporting pharma, medical device, diagnostics, and digital health organizations in analytics, regulatory strategy, innovation, and commercialization.

We partner with global healthcare organizations to navigate complex regulatory landscapes and accelerate market access across multiple geographies. With experience spanning 60+ countries, Healthark brings a deep understanding of international regulatory frameworks and local compliance requirements.

Position: Regulatory Affairs Specialist

Experience: 8+ years

Location: Bangalore / Hyderabad

Company URL: https://healtharkinsights.com/

Position Overview

We are seeking an experienced Regulatory Affairs Specialist to drive end-to-end regulatory submissions and approvals for In Vitro Diagnostic (IVD) and Medical

Device products across global markets.

The ideal candidate will have strong expertise in international regulatory frameworks including EU MDR, IVDR, US FDA 510(k)/PMA pathways, and other global registration practices. This role requires cross-functional collaboration, strategic regulatory planning, and lifecycle management of medical device registrations.

Job Description

The Regulatory Affairs Specialist will be responsible for preparing, managing, and maintaining regulatory submissions while ensuring compliance with evolving global regulatory standards. The role involves close coordination with R&D, Quality,

Manufacturing, and Commercial teams to align regulatory strategy with business objectives.

Key Responsibilities

• Global Regulatory Submissions
• Prepare and manage global submission dossiers for IVD and medical device registrations (EU, US, APAC, LATAM, Middle East, Africa).
• Lead medium-scale global submission and lifecycle maintenance projects.
• Coordinate responses to regulatory authority queries and support Notified Body interactions.
• Regulatory Compliance & Strategy
• Interpret and apply global regulatory requirements throughout the product lifecycle.
• Ensure compliance with EU MDR, IVDR, US FDA 510(k)/PMA, and other international frameworks.
• Review technical documentation, labeling, and promotional materials for compliance.
• Monitor evolving global regulatory changes and assess their impact on existing registrations.
• Technical Documentation & Risk Management
• Review and manage technical files, design dossiers, and risk management documentation.
• Ensure proper documentation practices aligned with regulatory standards.
• Maintain accurate and up-to-date regulatory documentation systems and databases.
• Cross-Functional Collaboration
• Collaborate with R&D, Quality, Manufacturing, and Commercial teams to align regulatory strategy with business needs.
• Provide regulatory guidance during product development and lifecycle management.
• Foster a collaborative environment to achieve regulatory and organizational objectives.

Required Skills & Qualifications:

Education & Experience:

• Bachelor’s or Master’s degree in Life Sciences, Engineering, or a related field.
• Minimum 8 years of experience in Regulatory Affairs for IVDs or Medical Devices.

Technical Expertise

• Strong knowledge of EU MDR, IVDR, US FDA 510(k)/PMA pathways, and global registration processes.
• Hands-on experience with technical documentation, design dossiers, and risk management.
• Experience managing global regulatory submissions and lifecycle maintenance.

Other Skills

• Excellent communication and project management skills.
• Strong cross-functional collaboration capabilities.
• Familiarity with digital regulatory tools and document management systems.
• High attention to detail and strong documentation discipline.