Senior Clinical Research Associate

Role Overview

As a Senior Research Associate, you will be a cornerstone of our R&D function. This is not a role with a short runway — we are looking for someone who will own and evolve experimental programs from concept through to regulatory submission and beyond. You will design and execute experimental protocols, interpret results, drive continuous iteration, and embed yourself in our regulatory strategy — particularly navigating CDSCO frameworks for medical devices and biologics in India.

You will work closely with cross-functional teams in product development, clinical affairs, and quality assurance, anchoring every initiative in sound science and compliant practice.

Key Responsibilities

Experimental Design & Execution

• Lead design and execution of experimental protocols for biomedical devices and biomaterials

• Ensure GLP/GMP-compliant documentation and data integrity

• Drive iterative validation from feasibility to pre-clinical stages

• Develop analytical methods and resolve complex experimental challenges

Regulatory & Compliance (CDSCO)

• Manage regulatory strategy and submissions under MDR 2017

• Prepare and review design dossiers and technical documentation

• Coordinate testing, safety evaluations, and approvals with regulatory bodies

• Ensure audit readiness, post-market surveillance, and CAPA compliance

Innovation & R&D

• Contribute to new product ideation, feasibility, and technology scouting

• Support IP generation and patent documentation

• Collaborate with academic, clinical, and industry partners

• Represent the organization in scientific and regulatory forums

Cross-functional Leadership

• Collaborate with quality, manufacturing, and clinical teams for product development

• Mentor junior researchers and enforce best practices

• Manage external partners (CROs, labs, consultants)

• Support risk management activities (ISO 14971)

Educational Background

•   B.Tech / M.Tech / M.Sc / Ph.D in Biomedical Engineering, Biotechnology, Biomedical Sciences, or closely related discipline

•   Advanced degree (M.Tech or Ph.D) strongly preferred for senior designation

Core Technical Experience

•   4–10 years of hands-on experience in a biomedical, biotech, or MedTech R&D environment

•   Demonstrated experience designing and executing experimental protocols with documented outcomes

•   Proficiency in characterization techniques such as SEM, FTIR, DSC, cell viability assays, mechanical testing, or equivalent

•   Experience with biocompatibility testing standards (ISO 10993) and/or sterility / packaging validation

Regulatory Knowledge — CDSCO (Essential)

•   Working knowledge of CDSCO Medical Device Rules 2017 and subsequent amendments

•   Familiarity with CDSCO submission formats, Class A/B/C/D classification, and product approval pathways

•   Experience preparing or supporting regulatory dossiers, technical files, or pre-submission meetings

•   Awareness of BIS standards, ISO 13485 QMS, IEC 60601, and related harmonized standards

Soft Skills & Mindset

•   Deeply curious and self-driven — someone who reads beyond the assignment

•   Long-term thinker who values institutional knowledge and continuous documentation

•   High tolerance for ambiguity and iterative scientific failure — resilience is essential

•   Excellent written and verbal communication — able to convey complex science to non-specialists

•   Collaborative team player with a sense of ownership and commitment.

How to Apply

Send your CV, a brief cover letter describing your most significant experimental or regulatory project, and any supporting materials (publications, patents, dossiers — even redacted) to:

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