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

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

Regulatory Leadership

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

Cross-Functional Influence

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

People & Team Leadership

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

Requirements:

Experience

1. 10-12+ years of experience in evidence generation, scientific communications or regulatory and clinical affairs,
2. Prior experience in wearables and/or medical devices preferred(digital health, diagnostics, wearables, Class II/III devices, or related).
3. Proven track record of leading programs of global partnerships, regulatory submissions and clinical programs.
4. Experience interacting with international regulatory bodies and managing multi-country studies is an added plus.

Education

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

Skills & Attributes

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

Other Expectations

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