Project Manager / Specialist

Role Summary:

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:

1. 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.

• 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.

• Oversee technical aspects of project execution, including RD and production processes.

• Provide insights into product design, development, and testing phases.

• Ensure technical feasibility and address challenges during project implementation.

• 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.

• Act as the primary point of contact for internal and external stakeholders.

• Communicate project updates, challenges, and progress effectively to all stakeholders.

• Foster collaboration across departments to achieve project milestones.

• Identify potential risks and develop mitigation strategies to minimize project impact.

• Ensure quality and compliance standards are met throughout the project lifecycle.

Qualifications and Skills:

• Bachelor s degree in Engineering, Business Administration, or a related field. A Master s degree is preferred.

• Proven experience in managing projects in the medical device or healthcare industry.

• Strong understanding of medical device manufacturing processes and regulatory frameworks (e.g., ISO 13485, MDR, FDA regulations).

• Excellent project management skills, with proficiency in tools like MS Project or equivalent.

• Exceptional communication, leadership, and problem-solving abilities.

• Ability to work in a fast-paced, dynamic environment and manage multiple priorities.

Preferred Certifications:

• PMP (Project Management Professional) or PRINCE2 certification.

• Certification in Regulatory Affairs or equivalent is an added advantage.