Certification Program Manager

Description

We pull medical technology from the future to solve human health.

Scarlet is authorised to assess and certify medical devices. We combine clinical, technical and regulatory expertise with AI agents and software so rigorous certification can keep pace with product development at the world’s most ambitious technology companies, without lowering the safety bar.

Our customers have cut a year or more from their certification timelines for new AI-enabled medical devices and shortened product-update cycles from months to weeks. You’ll join a team building the infrastructure that makes these outcomes repeatable at scale.

About the role

As a Certification Program Manager at Scarlet, you will help safe medical technologies reach patients sooner by running and improving the operations behind their certification.

You will own operational delivery across customer certification programs, working closely with auditors, assessors and account managers. This is a hands-on role: delivering detailed work accurately and on time, while finding ways to make certification simpler and more efficient.

As Scarlet expands into new markets and jurisdictions, you will help shape the processes that support that growth. You’ll build expertise across a varied range of certification activities, with scope to take ownership of broader operational improvements.

Responsibilities

• Plan and coordinate certification programs, including client considerations and audit time calculations, and improve how milestones, dependencies and follow-up activities are managed.
• Review applications and shape project plans, identifying device codes, required assessments and assessor competence requirements, while streamlining routine checks.
• Prepare certificates following approved certification decisions and coordinate surveillance and renewals, simplifying administration.
• Streamline certificate transfers by coordinating next steps with customers and outgoing certification bodies.
• Triage medical device change notifications and coordinate the appropriate specialist review, improving how changes are categorised and routed.
• Keep customers and colleagues informed of progress, outstanding actions and next steps.
• Work with product and engineering to improve procedures and automate routine workflows, so your work increasingly focuses on the most complex customers and cases.
• Required qualifications
• 3+ years’ experience in operations, project delivery, or a related discipline. You’ve owned detailed projects or workflows from planning through completion, meeting agreed deadlines and communicating complex information clearly.
• Strong analytical background. A degree or equivalent in Science, Technology, Engineering, and Mathematics, or another analytically demanding subject, or comparable achievement through technical work, research or independent projects.
• Evidence of solving difficult problems independently. You can explain an unfamiliar problem you tackled, how you broke it down, the decisions you made and the result you achieved.
• An eye for detail. Experience reviewing detailed documents or data for completeness and accuracy.
• Preferred qualifications
• Experience in healthcare, certification or another regulated industry.
• Knowledge of medical technology and the role of certification.
• Interview process
• Introductory call with Sarah — 20 minutes.
• Interview with Nadine / Sasha — 45 minutes. Review a case study, prioritise actions and suggest an improvement. All relevant process rules will be provided.
• Interview with Sarah — 45 minutes. Review a case study, prioritise actions and suggest an improvement. All relevant process rules will be provided.
• Interview with Tiri , James , and Jamie — 20 minutes each. Values and working style interviews.
• Offer & references.