Product Manager

**Product Manager - HealthVector®
**About Us**

Mesh Bio a leading Healthcare Technology company revolutionizing healthcare with our cutting-edge digital twin software as a medical device (SaMD). Mesh Bio has received international recognition and accolades:
Our innovative solutions empower clinicians and healthcare providers to predict and prevent chronic disease complications, improving patient outcomes worldwide. We are looking for a dynamic and experienced Product Manager to join our team and lead the launch, regulatory approval, and market expansion of our groundbreaking digital health solutions.

**Role Overview**

As a Product Manager, you will be responsible for driving the success of our novel digital twin SaMD, leading its market launch, achieving product-market fit, and expanding its presence globally. You will play a crucial role in navigating the regulatory landscape, securing product registration in new markets, and driving the FDA approval process in the US, along with obtaining reimbursement. This is a unique opportunity to shape the future of digital health technology and make a tangible impact on global healthcare.

**Key Responsibilities**

1. Launch and Product Market Fit

a. Lead the development and execution of a comprehensive go-to-market strategy for our digital twin SaMD, including product positioning, messaging, pricing, and distribution.

b. Collaborate closely with the marketing, sales, clinical, and engineering teams to ensure alignment on product goals, timelines, and launch plans.

c. Identify key market segments and customer personas to target for early adoption, pilot programs, and strategic partnerships.

d. Develop and manage relationships with key opinion leaders (KOLs), healthcare providers, and other stakeholders to drive product awareness, adoption, and endorsement.

e. Oversee the creation of sales enablement tools, training programs, and marketing collateral to support the commercial launch.

f. Analyze market trends, customer feedback, and competitive landscape to refine product features, value propositions, and overall market strategy.

g. Track and report on key performance metrics to measure product-market fit and inform continuous improvement efforts.

2. Regulatory Strategy and Market Expansion

a. Lead product registration and regulatory approval efforts in new markets, such as Indonesia and Malaysia.

b. Develop and execute regulatory strategies to ensure compliance with local, regional, and international standards.

c. Work with local regulatory consultants, partners, and authorities to navigate regulatory requirements and obtain necessary approvals.

d. Collaborate with cross-functional teams to align regulatory strategies with broader business goals and timelines.

3. FDA Approval and Reimbursement

a. Lead the FDA approval process for our digital twin software in the US, including developing submission strategies, managing documentation, and liaising with regulatory authorities.

b. Work closely with legal and regulatory affairs teams to ensure all regulatory requirements are met and submissions are completed on time.

c. Develop and implement strategies to secure reimbursement, including engaging with payers, advocating for coverage, and creating value dossiers and health economic models to demonstrate product benefits and cost-effectiveness.

d. Monitor changes in reimbursement policies and regulations, and adjust strategies accordingly to maximize reimbursement opportunities.

4. Commercialization and Market Growth

a. Develop and manage the product roadmap to align with market needs, business objectives, and regulatory requirements.

b. Identify and establish partnerships with healthcare providers, distributors, and other channel partners to expand market reach and drive product adoption.

c. Create and execute strategies to support the scaling of the product in new and existing markets, including localization, training, and support.

d. Work with sales teams to set commercial targets, monitor performance, and adjust strategies to meet revenue goals.

e. Stay informed on industry trends, competitor activities, and emerging technologies to ensure the product remains competitive and aligned with market demand.

**Qualifications**
- Proven experience in product management, preferably in the healthtech, medtech, or digital health sectors.
- Strong knowledge of regulatory requirements for software as a medical device (SaMD) in multiple regions, including US FDA, CE Mark, and other relevant jurisdictions.
- Experience in launching digital health products and achieving product-market fit.
- Demonstrated experience in leading product registration and regulatory approval processes in multiple markets.
- Excellent communication, leadership, and project management skills.
- A passion for innovation in healthcare and improving patient outcomes.

**What We Offer**
- Opportunity to work on cutting-edge digital health solutions with a global impact.
- A dynamic and