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
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.
Risk Management
- 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.