Project Manager/ Specialists

Trivitron Healthcare; Dadri; On-site; INR 1,500,000 - 2,300,000; Full time

Job summary

Trivitron Healthcare is seeking a Project Manager / Specialist to lead cross-functional projects within the medical device and healthcare space. You will align objectives, plan timelines and budgets, and coordinate with R&D, production, and commercial teams to ensure successful delivery.

The role requires strong regulatory knowledge (ISO 13485, MDR, FDA) and exceptional communication and leadership skills to drive projects from concept to implementation in a fast-paced environment.

Qualifications

• Bachelor’s degree in Engineering, Business Administration, or a related field (Master’s preferred).
• Proven experience managing projects in the medical device or healthcare industry.
• Strong understanding of medical device manufacturing and regulatory frameworks (ISO 13485, MDR, FDA).
• Excellent project management skills with tools such as MS Project or equivalent.
• Exceptional communication, leadership, and problem-solving abilities.
• Ability to thrive in a fast-paced, dynamic environment while managing multiple priorities.

Responsibilities

• Define project objectives, scope, and deliverables in alignment with organizational goals.
• Develop detailed project plans, timelines, and budgets to ensure timely completion.
• Coordinate with cross-functional teams to manage project activities effectively.
• Identify business opportunities and develop strategies to enhance market positioning.
• Collaborate with sales and marketing teams to drive customer-focused initiatives.
• Oversee technical aspects of project execution, including R&D and production processes.
• Ensure adherence to national and international medical device regulations.
• Maintain documentation to support regulatory audits and inspections.
• Act as the primary point of contact for internal and external stakeholders.
• Communicate project updates, challenges, and progress effectively.
• Foster collaboration across departments to achieve project milestones.
• Identify potential risks and develop mitigation strategies.
• Ensure quality and compliance standards throughout the project lifecycle.

Job description

We are seeking a dynamic and detail-oriented Project Manager / Specialist to lead and execute special projects within our organization. This role requires a unique blend of commercial acumen, technical expertise, and regulatory knowledge to ensure the seamless execution of cross-functional projects that drive organizational growth and compliance.

Key Responsibilities

Project Planning and Execution

• Define project objectives, scope, and deliverables in alignment with organizational goals.
• Develop detailed project plans, timelines, and budgets to ensure timely completion.
• Coordinate with cross-functional teams to manage project activities effectively.

Commercial Strategy and Collaboration

• Identify business opportunities and develop strategies to enhance market positioning.
• Collaborate with sales and marketing teams to drive customer-focused initiatives.
• Evaluate commercial viability and ensure alignment with business objectives.

Technical Oversight

• Oversee technical aspects of project execution, including R&D and production processes.
• Provide insights into product design, development, and testing phases.
• Ensure technical feasibility and address challenges during project implementation.

Regulatory Compliance

• Ensure adherence to national and international medical device regulations.
• Collaborate with regulatory teams to obtain necessary certifications and approvals.
• Maintain documentation to support regulatory audits and inspections.

Stakeholder Management

• Act as the primary point of contact for internal and external stakeholders.
• Communicate project updates, challenges, and progress effectively.
• Foster collaboration across departments to achieve project milestones.
• Identify potential risks and develop mitigation strategies.
• Ensure quality and compliance standards throughout the project lifecycle.

Qualifications & Skills

• Bachelor’s degree in Engineering, Business Administration, or a related field (Master’s preferred).
• Proven experience managing projects in the medical device or healthcare industry.
• Strong understanding of medical device manufacturing and regulatory frameworks (ISO 13485, MDR, FDA).
• Excellent project management skills with tools such as MS Project or equivalent.
• Exceptional communication, leadership, and problem-solving abilities.
• Ability to thrive in a fast-paced, dynamic environment while managing multiple priorities.

Preferred Certifications

• PMP (Project Management Professional) or PRINCE2 certification.
• Certification in Regulatory Affairs or equivalent is an added advantage.