Operations Manager

**Position Title**: Operations Manager
**Location**:700 Swanston Street, Carlton, Victoria
**Employment Type**: Full-Time Hybrid (2 days remote, 3 days in-office)
**Reporting to**:CEO
**Desired Start Date**: July 1st 2025 (or sooner if available)

**About Kali Healthcare**
Kali Healthcare is a health technology company dedicated to transforming pregnancy care. Founded by a multidisciplinary team of clinicians and engineers, we develop wearable technologies and digital health tools designed to enhance pregnancy monitoring. Our platform aims to empower clinicians with novel capabilities to detect and manage pregnancy complications and improve access to high quality care for expectant parents.

At Kali Healthcare, creating a better world for mothers, babies and their families is at the heart of everything we do. To achieve this, we foster a culture of high agency, proactive problem solving and respectful collaboration, where every team member’s voice matters.

**About the Role**

Kali Healthcare is looking for an outstanding Operations Manager to help take our first medical device through to market launch and realise our vision of improving pregnancy care. Our Operations Manager needs to be technically excellent with a process-driven mindset. In this role you will have a hand in guiding all company activities, from helping manage product development, supporting clinical partners, and engaging with regulatory agencies. Working closely with our CEO, you will play a key role in shaping the company as it grows in bringing our first product to market.

**Responsibilities**

1. Product Management:

- Coordinate activities across multidisciplinary internal teams (engineering, clinical, commercial) and external stakeholders
- Develop, implement and manage effective people and task management systems, including project tracking tools (Jira), and internal documentation systems (Confluence) with technical expertise to adopt AI-enabled processes
- Engage directly in technical and engineering tasks related to electronics and software development, including problem-solving technical challenges, providing hands-on support, and facilitating technical reviews
- Help lead and support a diverse team of engineers and administrative staff, promoting a proactive, collaborative, and innovative workplace culture
- Facilitate activities required for transitioning product design to manufacturing

2. Clinical, Regulatory and Compliance:

- Collaborate with clinical and regulatory consultants to manage regulatory submissions, ensuring regulatory documents and filings are accurate and aligned with commercial requirements
- Contribute to continuous improvement of Kali Healthcare’s ISO13485 Quality Management System to ensure compliance

3. Commercial Development:

- Act as the liaison between internal clinical/engineering teams and external commercial stakeholders, facilitating feedback loops, and issue resolution
- Engage proactively with commercial stakeholders to streamline product feature development, resolve technical or operational challenges, and ensure smooth integration into customer workflows

4. Planning and Cost Expenditure:

- Contribute to managing operational budgets and expenditure plans
- Work closely with the finance team on financial planning, and grant progress reporting, to ensure accurate, compliant, and timely submissions

**Desirable Skills**
- Proven experience managing projects with complex interdependencies (e.g. product development, clinical trials, regulatory submissions)
- Familiarity with medical device lifecycle management, ISO 13485, risk-based product development, FDA and/or TGA submissions
- Strong organizational, communication, technical, and stakeholder management skills
- High agency and a proactive approach to problem-solving
- Strong leadership, strategic thinking, and ability to manage multiple concurrent projects in a dynamic startup environment

**Qualifications and Other Requirements**
- Minimum Bachelor’s Degree in Engineering, Computer Science, or related technical field (Higher degrees such as Masters and PhD will also be well received)
- Minimum of 3 years of relevant industry experience in Class II or Class III medical device development
- Must have Australian citizenship/permanent residence or an appropriate visa with full-time working rights
- Must be located or willing to relocate to Melbourne

**Benefits**
- Competitive salary package + employee share option plan (ESOP)
- Hybrid working arrangement
- Dynamic, collaborative, and creative startup environment

**How to Apply**

1. A detailed CV/resume highlighting your relevant experience in **medical device development**
2. A brief cover letter explaining your suitability for the role, including **specific examples of relevant achievements