Job Summary
The Head - Business Development will oversee Topia MedTech's business operations in India, focusing on regulatory affairs for medical devices and spearheading business development initiatives in the US, EU, and UK. This role requires a strategic leader with deep expertise in navigating complex regulatory landscapes (including FDA 510(k), UKCA, and EU MDR) and proven success in expanding medtech markets. You will play a pivotal role in ensuring compliance, fostering partnerships, and driving revenue growth in high-potential regions.
Key Responsibilities
- Regulatory Affairs Leadership: Manage and execute regulatory strategies for product approvals and compliance in global markets. This includes preparing and submitting 510(k) filings for FDA clearance in the US, UKCA certifications for the UK market, and compliance with EU Medical Device Regulation (MDR) requirements.
- Business Development: Identify and pursue growth opportunities in the US, EU, and UK, including market entry strategies, partnership development with healthcare providers, distributors, and tech firms, and sales pipeline management to achieve revenue targets.
- Market Expansion in India: Oversee local operations, including team management, supply chain optimization, and collaboration with R&D teams in Ahmedabad and Vadodara to align product development with regional needs.
- Strategic Planning: Develop and implement business plans, forecasts, and budgets for India-based operations while aligning with global objectives. Analyze market trends in medtech, regulatory changes, and competitive landscapes to inform decision-making.
- Stakeholder Management: Build and maintain relationships with regulatory bodies (e.g., FDA, MHRA, EU Notified Bodies), key opinion leaders, investors, and internal teams across geographies.
- Compliance and Risk Management: Ensure all activities adhere to international standards, conduct audits, and mitigate risks related to regulatory and business operations.
- Team Leadership: Recruit, mentor, and lead a cross-functional team in India, fostering a culture of innovation and excellence.
- Performance Metrics: Track KPIs such as regulatory approval timelines, market penetration rates, revenue growth, and partnership success, reporting regularly to senior leadership.
Qualifications and Experience
- Education: Bachelor's degree in Business Administration, Engineering, Life Sciences, or a related field; MBA or advanced degree preferred.
- Professional Experience: 10+ years in the medtech or healthcare industry, with at least 5 years in a senior leadership role focused on regulatory affairs and business development.
- Regulatory Expertise: Proven track record with FDA 510(k) submissions, UKCA marking processes, and EU MDR compliance, including hands-on experience in dossier preparation, audits, and post-market surveillance.
- Business Development Skills: Demonstrated success in expanding markets in the US, EU, and UK, including deal negotiation, strategic alliances, and achieving sales targets in medtech or related sectors.
- India-Based Operations: Experience managing teams or operations in India, with knowledge of local regulations (e.g., CDSCO) and market dynamics.
- Technical Knowledge: Familiarity with medical devices, AI in healthcare, wearables, and imaging technologies; understanding of ISO 13485, quality management systems, and clinical trials is a plus.
- Skills: Strong leadership, communication, and negotiation abilities; analytical mindset with proficiency in market research tools; ability to work in a fast-paced, global environment.
- Other Requirements: Willingness to travel internationally (up to 30%); fluency in English required, additional languages (e.g., Hindi, German, French) advantageous.
What We Offer
- Competitive salary and performance-based incentives.
- Opportunities for professional growth in a cutting-edge medtech environment.
- Comprehensive benefits package, including health insurance and relocation support if needed.
- Chance to contribute to innovative solutions impacting global health.
