R&D Clinical Product Manager

Job Title: R&D Clinical Product Manager

Location: Sec 62 Noida

Type: Full-Time

Reports To: [Founder / CEO / VP of Product]

Position Overview

We are seeking a versatile and hands-on R&D Clinical Product Manager to drive our biotech product from early concept and laboratory development through clinical validation and regulatory readiness.

In this role, you will bridge technical R&D with clinical application. You will translate clinical user needs into technical product requirements, oversee day-to-day R&D execution, manage external clinical and manufacturing vendors (CROs/CDMOs), and work closely with our external FDA/Regulatory Consultant to ensure all development meets regulatory standards.

Key Responsibilities

1. Product Development & R&D Execution

Translate clinical insights, user feedback, and physician requirements into clear, technical product specifications and design controls.

Oversee day-to-day bench science, laboratory testing, and product prototyping to meet key performance and safety milestones.

Manage relationships and workflows with external Contract Research Organizations (CROs), Contract Development & Manufacturing Organizations (CDMOs), and technical vendors.

2. Clinical Strategy & Execution

Coordinate pre-clinical, feasibility, and early-phase clinical study operations.

Assist in drafting clinical protocols, study reports, investigator brochures, and informed consent forms.

Serve as the primary liaison between internal development teams and external clinical investigators, clinical sites, or medical advisers.

Synthesize clinical feedback and safety data to iteratively improve product design and usability.

3. Regulatory & Quality Integration

Partner directly with external Regulatory Affairs Consultants to gather, prepare, and organize data required for FDA submissions (e.g., Pre-IND, IND, 510(k), IDE, or BLA/PMA).

Maintain rigorous documentation, design history files (DHF), and quality management system (QMS) records compliant with regulatory standards (e.g., ISO 13485, Good Laboratory Practice / GLP, Good Clinical Practice / GCP).

4. Project & Timeline Management

Develop, track, and manage cross-functional product development timelines, budgets, and deliverable schedules.

Identify technical or operational risks early and propose practical, solutions-oriented mitigation plans.

Qualifications & Requirements

Education: Advanced degree (MS, PhD, PharmD) or BS/BSN with equivalent industry experience in Biomedical Engineering, Biotechnology, Biological Sciences, or a related clinical/technical field.

Experience: 3–6 years of hands-on experience in biotech, medical device, diagnostic, or pharmaceutical R&D, with a strong focus on clinical translation or product development.

Clinical & Regulatory Knowledge:

Direct exposure to clinical study coordination, protocol writing, or GCP/GLP environments.

Familiarity with FDA regulatory pathways and design control processes.

Project Management: Proven ability to manage technical projects, keep lab/vendor timelines on track, and manage multi-stakeholder workflows.

Soft Skills: Excellent cross-functional communication skills—able to speak fluently with engineers/scientists, clinicians/physicians, and regulatory advisors.

Interested Candidates reach us out at - 8800231627 or hrdepartment@cosma.health