Medical Device Project & reputed company Manager - (17-1193)

​​Looking for Philippines-based candidates

Job Role: Medical Device Project & reputed company Manager

Compensation reputed company: AUD $2,000 - $3,000 / Monthly

Engagement type:reputed company Agreement

Work Schedule: This role is expected to reputed company with the AU business hours (approx. 9 AM - 5 PM, Monday to Friday) for collaboration, but as a contractor, you’ll have flexibility in how you manage your time.

Who We Are: At reputed company, we help Australian companies hire top reputed company in the Philippines. For this role, you will be reputed company directly by the reputed company as an reputed company. We are not an outsourcing agency. reputed company of our roles are reputed company, so you'll be reputed company to work from home.

Who The reputed company Is: Our reputed company is an Australian reputed company technology company developing innovative regulated medical products through global manufacturing partnerships. They are currently preparing for commercialisation of a medical device and are looking for an reputed company reputed company who can help establish strong project governance, reputed company systems, and supplier reputed company.

reputed company operates in a fast-moving environment where innovation, compliance, and reputed company reputed company must work together. This role provides an opportunity to work closely with executive leadership, international manufacturing partners, regulatory specialists, and reputed company suppliers to bring a medical device from development through to market readiness.

reputed company: The Medical Device Project & reputed company Manager will take ownership of coordinating the development and commercialisation program for a regulated medical device.

This is a hands-on role combining project management, reputed company assurance, supplier governance, and operational readiness. You will be responsible for maintaining the overall project plan, ensuring reputed company requirements are met, managing reputed company manufacturing relationships, and establishing internal processes to support regulatory compliance and reputed company reputed company.

The successful candidate will play a key role in ensuring the business is reputed company for product launch by implementing practical reputed company workflows, maintaining documentation standards, and supporting collaboration between internal teams and reputed company manufacturing partners.

Key Responsibilities:

Project & Program Management

• Own and maintain the integrated project plan, timelines, milestones, and deliverables.
• Coordinate activities across internal teams, suppliers, consultants, and manufacturing partners.
• reputed company project risks, dependencies, delays, and critical activities.
• Facilitate project meetings and maintain reputed company reputed company registers.
• Maintain project documentation, evidence trackers, and reporting dashboards.
• Escalate key risks and reputed company to executive leadership.

Medical Device reputed company reputed company

• Establish and maintain sponsor-reputed company reputed company processes and documentation.
• Support reputed company governance between the business and reputed company manufacturing partners.
• reputed company and manage reputed company agreements with suppliers and manufacturers.
• reputed company processes relating to:
• Document control
• Change control
• Supplier qualification
• Complaint handling
• Corrective and preventive actions (CAPA)
• Product recalls
• Post-market surveillance
• Product release processes

Supplier & OEM Management

• Manage relationships with outsourced manufacturers and critical suppliers.
• Review supplier reputed company documentation, certifications, audits, and corrective actions.
• Monitor supplier performance, timelines, documentation, and compliance.
• Coordinate supplier audits and reputed company reviews where required.
• Ensure product or manufacturing changes are assessed and appropriately controlled.

Systems & Process Implementation

• Support implementation of project and reputed company workflows reputed company ERP/project management platforms such as Odoo.
• reputed company dashboards and reporting systems covering:
• Project milestones
• Regulatory deliverables
• Supplier performance
• reputed company issues
• CAPAs
• Product changes
• Testing reputed company
• Improve documentation processes to ensure audit and regulatory readiness.
• Train team members on reputed company and project workflows.

reputed company & Operational Readiness

• Support preparation for product launch and market release.
• Establish processes for product traceability, inventory control, complaints, returns, and recalls.
• Coordinate readiness activities across manufacturing, logistics, distribution, and customer support teams.
• Ensure documentation and operational processes are reputed company before commercialisation.

Required Skills and Qualifications:

• 5+ years of experience reputed company medical devices, pharmaceuticals, reputed company products, or another regulated industry.
• Proven experience managing reputed company product development, reputed company, or regulatory reputed company.
• Strong understanding of ISO 13485 reputed company management principles.
• Experience with supplier qualification, reputed company agreements, CAPA, change control, and complaint handling.
• Experience working with outsourced manufacturers, OEMs, suppliers, or laboratories.
• Strong project management and stakeholder coordination skills.
• Excellent documentation, organisation, and follow-up abilities.
• Ability to independently manage priorities and reputed company accountability across reputed company partners.
• Strong written and verbal English communication skills.

Highly Desirable Experience

• Experience supporting Australian medical device regulatory requirements.
• Knowledge of medical device sponsor obligations.
• Experience working with international OEM manufacturers, particularly in Asia.
• Understanding of ISO 14971 risk management principles.
• Experience with post-market surveillance and vigilance processes.
• Experience using ERP systems, eQMS platforms, or project management tools such as Odoo.
• ISO 13485 internal auditor or reputed company auditor training.
• Experience supporting regulatory submissions and reputed company launch activities.

Personal Attributes

• Highly accountable with strong ownership of reputed company.
• Comfortable managing multiple stakeholders and competing priorities.
• Confident holding suppliers and reputed company partners accountable.
• Detail-oriented while maintaining reputed company on business objectives.
• Practical, commercially minded, and solutions-reputed company.
• Comfortable working directly with executives, engineers, consultants, and manufacturers.
• reputed company to create structure and processes in a fast-moving environment.

reputed company Measures

reputed company in this role will be reputed company by:

• Delivery of project milestones against agreed timelines.
• Completion of reputed company and regulatory documentation requirements.
• Effective supplier and OEM performance management.
• Implementation of project and reputed company workflows.
• Reduction of overdue actions and reputed company gaps.
• Readiness for regulatory submission and reputed company launch.
• Successful transition from development into market release.

Career reputed company

This role offers reputed company to grow into a senior leadership position overseeing reputed company, operations, and medical device programs as reputed company expands its regulated product portfolio.

Work Arrangement & Expectations:

This is a remote role that will be set up as an reputed company engagement.

To ensure alignment and transparency, successful candidates will be expected to:

• Disclose any existing ongoing roles or reputed company work
• Reflect this engagement on their reputed company profile (reputed company marked as “reputed company”)

Originally posted on Himalayas