Project Manager – Medical Device Manufacturing & Regulatory Coordination
Employer: Digivitals
Location: Noida, India
Employment Type: Full-time
Industry: Medical Devices / HealthTech / Healthcare Technology
Posting Date: June 01, 2026
Application Deadline: June 30, 2026
About the Role
Digivitals is seeking an experienced Project Manager to coordinate medical device development, manufacturing, regulatory activities, and vendor management. The role involves working with internal teams, manufacturers, testing labs, regulatory consultants, and certification agencies to ensure timely project execution and compliance. Travel to project-related locations may be required.
Key Responsibilities
- Manage project timelines, milestones, risks, deliverables, and dependencies.
- Coordinate with vendors, manufacturers, testing labs, certification bodies, and consultants.
- Support regulatory activities, licensing documentation, and certification processes.
- Prepare project plans, status reports, meeting minutes, and management presentations.
- Coordinate manufacturing activities including PCB production, assembly, testing, and packaging.
- Support ISO 13485/QMS documentation, document control, and audit preparation.
- Track project risks, resolve bottlenecks, and maintain project records.
- Coordinate clinical study activities and stakeholder communications.
- Provide regular project updates to management.
Required Qualifications
- Bachelors in engineering, biomedical, life sciences, or related field.
- Minimum 5 years of project management experience.
- Strong communication, documentation, and stakeholder management skills.
- Experience with project planning, risk management, and task tracking.
- Proficiency in JIRA, Confluence, MS Excel, Word, and PowerPoint.
- Willingness to travel as required.
Preferred Qualifications
- MBA
- Experience in medical device or healthcare technology industries.
- Knowledge of CDSCO regulations and medical device licensing.
- Familiarity with ISO 13485 and QMS processes.
- Experience coordinating with regulatory agencies, testing labs, and manufacturers.
- Exposure to IoT, wearable, diagnostic, or patient-monitoring devices.
Key Skills
- Project Management (JIRA, Confluence, MS Office)
- Regulatory & Compliance Coordination
- Vendor & Manufacturing Management
- ISO 13485 / QMS Support
- Clinical Study Coordination
- Risk Management & Reporting
- Communication & Stakeholder Management
How to Apply
Please send your resume and a brief cover letter via email.
Apply Now