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Senior Leader, Clinical Research & Regulatory Affairs
Senior Leader, Clinical Research & Regulatory AffairsMetaMorph • Bengaluru, Republic Of India, IN
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Senior Leader, Clinical Research & Regulatory Affairs

Senior Leader, Clinical Research & Regulatory Affairs

MetaMorph • Bengaluru, Republic Of India, IN
4 days ago
Job description

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 angle—360°

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 Client’s 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.
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    Clinical Research • Bengaluru, Republic Of India, IN

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