General Manager - Medical Devices - Wake Forest, NC
We are seeking an accomplished and strategic General Manager to lead the US operations of a growing Medical Devices organisation from Wake Forest, NC. This is a pivotal executive role with full P&L ownership, responsibility for operational excellence, and accountability for delivering significant growth in a highly regulated healthcare environment. The ideal candidate is a proven leader who excels in scaling organisations, driving cross-functional performance, and building high-performing teams.
In this role, you will take full ownership of the US P&L, ensuring strong revenue delivery, cost control, margin optimisation, and overall financial performance. You will develop and execute the US strategic plan in alignment with corporate objectives and shareholder expectations, while also overseeing sales, marketing, and business development activities to expand market share and support an ambitious pathway to more than $100M in annual revenue. A key part of the position involves ensuring full compliance with FDA regulations, CMS requirements, ISO 13485 quality systems, and all applicable healthcare laws.
You will lead supply chain, manufacturing, and distribution operations to meet demand, uphold quality standards, and maintain delivery commitments. As a people leader, you will build, mentor, and manage the US senior leadership team and wider workforce, fostering a culture of accountability, innovation, and continuous improvement. You will also manage relationships with key customers, distributors, payers, and strategic partners to strengthen market presence and support long-term growth. The role includes responsibility for budgeting, forecasting, capital allocation, and financial reporting, with regular updates provided to the Board. You will identify and mitigate operational, regulatory, and market risks, while championing innovation, process optimisation, and operational excellence across all US functions.
We are looking for someone with proven experience in a senior operational or general management role within healthcare, medical devices, diagnostics, or a similarly regulated industry. You will bring a strong understanding of FDA, CMS, and ISO 13485 requirements, along with a track record of scaling operations and delivering significant revenue growth. Exceptional leadership, communication, and stakeholder management skills are essential, as is a data-driven, strategic mindset paired with hands-on execution capability. The ability to thrive in a fast-paced, high-accountability environment will be key to success.
This is a rare opportunity to lead and shape the future of a rapidly growing US business with strong global backing. You will have the autonomy, resources, and influence to drive meaningful impact across the organisation and the wider industry.
To explore this opportunity further, contact Andrew Welsh, Director of Medical Devices, Biotech and DeepTech Recruitment at Newton Colmore, on (phone number removed). Alternatively, submit your CV and a member of our team will be in touch to discuss next steps