VP Scientific and Clinical Affairs | Global Medtech

ABOUT METAMORPH:

We at MetaMorph, empower organizations to scale and innovate by placing people at the center of their strategy. With a proven track record of supporting over 220 orgs, we specialize in aligning talent with their needs, enhancing employee skills, and transforming employer brands. Our data-driven insights fuel decision-making and provide comprehensive support for both acquisition and being acquired, ensuring you are covered from every angle360

About Our Client:

A next-gen health and performance platform built to help individuals optimize their metabolic fitness offering intelligent wearables, real-time biometric insights, personalized recommendations, and a connected ecosystem designed to improve daily lifestyle decisions and long-term well-being.

The Role:

The cross domain leadership role with a mix of evidence generation along with Regulatory & Clinical Affairs for global medical device markets. This leader will drive not only drive clinical validation programs, foster partnerships but also ensure regulatory compliance across multiple geographies, and serve as a strategic liaison between product, quality, clinical, engineering, and executive teams. The ideal candidate is articulate, confident, and adept at leading high-performance teams in fast-paced, innovation-driven environments.

Key Responsibility:

Evidence Generation and Clinical Affairs

• Lead and mentor a group of talented and diverse researchers
• Support business and product requirements with scientific evidence generation. Work across different verticals to ensure timely and precise validation assignments of new products.
• Manage partnerships with CROs, hospitals, academic collaborators, and principal investigators.
• Vetting scientific merit of incoming partnerships leads working closely with leadership
• Oversee ideation, design and execution of internal proof of concept and externally executed clinical studies
• Foster and expand a robust multi-themed publication schedule - posters, conferences, white papers, peer reviewed publications
• Foster and expand Client's varied research partnership roster, finding new avenues of R&D with academia
• Serve as ambassador for Clients scientific activities on offline and online platforms

Regulatory Leadership

• Develop and implement regulatory strategies for India, US, EU, and other priority markets.
• Oversee preparation and successful submission of regulatory filings (e.g., CDSCO, 510(k), CE Mark, ISO audits).
• Engage directly with regulatory authorities, notified bodies, and government agencies.
• Build and maintain compliance frameworks aligned with global medical device regulations (MDR, IVDR, QMS standards).

Cross-Functional Influence

• Act as a key strategic partner to executive leadership and contribute to long-term product planning.
• Work closely with leadership and heads of engineering, product, quality, and commercial teams to align regulatory and clinical requirements.
• Communicate clearly and persuasively with internal teams and external stakeholders.

People & Team Leadership

• Mentor junior staff and foster a culture of accountability, precision, and scientific integrity.
• Establish structured processes for documentation, data management, and compliance.

Requirements:

Experience

• 10-12+ years of experience in evidence generation, scientific communications or regulatory and clinical affairs,
• Prior experience in wearables and/or medical devices preferred(digital health, diagnostics, wearables, Class II/III devices, or related).
• Proven track record of leading programs of global partnerships, regulatory submissions and clinical programs.
• Experience interacting with international regulatory bodies and managing multi-country studies is an added plus.

Education

• Advanced degree in life sciences, biomedical engineering, medicine, or a related discipline.
• International education or research experience (mandatory), such as graduate studies abroad, international fellowships, or cross-border research collaborations.

Skills & Attributes

• Exceptional communication - clear, structured, and executive-ready.
• Strong analytical and scientific writing skills.
• High comfort working across multiple time zones and functions.
• Ability to operate independently with a strategic mindset.
• Strong leadership presence with the ability to influence C-suite decision-making.
• Highly organized, detail-oriented, and comfortable in regulatory ambiguity.

Other Expectations

• Based in India, preferably Bangalore .
• Willingness and ability to travel as needed.
• Comfortable in a transformative, fast-paced, globally distributed organization.