Project Coordinator

The Project Coordinator will play a key role in coordinating and managing cross-functional activities across Design, Quality, Manufacturing, Sales, and Regulatory departments to ensure the successful development, production, and distribution of medical devices. The individual will act as a liaison between departments, ensuring timely communication, efficient workflows, and compliance with industry standards and regulations.

**Key Responsibilities**:

- **Project Planning & Coordination**:

- Collaborate with teams across Design, Quality, Manufacturing, Sales, and Regulatory departments to develop detailed project plans.
- Maintain and update project schedules, ensuring alignment between various stakeholders.
- Coordinate the preparation and delivery of required documentation to meet project milestones.
- **Design & Development**:

- Work closely with the Design and R&D teams to track the progress of new product development.
- Facilitate communication between the Design team and Manufacturing to ensure designs are feasible and aligned with production capabilities.
- Ensure design specifications meet the required quality and regulatory standards.
- **Quality Assurance**:

- Coordinate with the Quality Assurance (QA) team to ensure product design and manufacturing processes meet the company's quality standards and comply with ISO 13485 and FDA regulations.
- Assist in the organization of quality reviews, audits, and corrective action processes.
- Ensure that all documentation related to quality, including testing and validation, is up to date and available for audits or inspections.
- **Manufacturing Coordination**:

- Act as the point of contact between the Manufacturing and Design teams to align on production timelines and material requirements.
- Monitor production schedules and ensure timely delivery of products.
- Assist in troubleshooting production-related issues and facilitate communication between departments for rapid resolution.
- **Sales & Marketing Support**:

- Collaborate with the Sales and Marketing teams to ensure they are informed about new product launches and updates.
- Assist in the preparation of product documentation and training materials for the Sales team.
- Coordinate between Sales and Manufacturing for accurate forecasting and inventory planning.
- **Regulatory Affairs**:

- Work with the Regulatory Affairs team to ensure products comply with applicable local and international medical device regulations (e.g., FDA, CE Marking, CDSCO).
- Ensure all regulatory submissions are completed on time, and proper documentation is maintained for audits and inspections.
- Assist in the coordination of clinical trials and regulatory certifications.
- **Communication & Reporting**:

- Serve as the primary point of contact for project updates, facilitating regular meetings and communication between departments.
- Prepare and distribute progress reports, meeting minutes, and action items.
- Track project performance using appropriate tools (e.g., Gantt charts, project management software) to ensure projects are completed on time and within scope.
- **Risk Management**:

- Identify and address potential risks across departments that could impact project timelines or compliance.
- Collaborate with teams to develop risk mitigation strategies.
- **Budget & Resource Management**:

- Monitor project budgets and resource allocations to ensure project objectives are met within financial constraints.
- Ensure optimal resource utilization across departments, coordinating with department heads for staffing and material needs.

**Required Skills and Qualifications**:

- Bachelor’s degree in Engineering, Business Administration, or a related field.
- 5-7 years of experience in project management, preferably within the medical device industry.
- Familiarity with medical device regulations (FDA, CE Mark, CDSCO, etc.).
- Strong organizational and multitasking skills with a proven ability to manage complex projects across multiple departments.
- Excellent communication and interpersonal skills to work with cross-functional teams.
- Proficiency in project management tools (e.g., Microsoft Project, Trello, Jira, Asana).
- Experience with quality management systems (ISO 13485, FDA QSR).
- Strong analytical skills and attention to detail.

**Job Types**: Full-time, Permanent

Pay: ₹50,000.00 - ₹70,000.00 per month

**Benefits**:

- Flexible schedule
- Health insurance
- Leave encashment
- Paid sick time
- Paid time off
- Provident Fund

Schedule:

- Monday to Friday

**Experience**:

- Medical device/ Electronics: 1 year (required)

**Language**:

- English (preferred)

Work Location: In person