Senior Program Manager, SaMD

United States Digital Space LLC; Boston (MA); On-site; USD 155,000 - 185,000; Full time

Job summary

United States Digital Space LLC is seeking aSenior Program Manager, SaMD in Boston to drive end-to-end SaMD programs from development through regulatory submission and launch. You will partner with ML, Product, Engineering, Clinical, Regulatory, and Quality teams to meet milestones and manage risks.

This execution-focused role requires experience across multiple concurrent SaMD initiatives and a strong grasp of 21 CFR 820, ISO 13485, IEC 62304, and ISO 14971.

Qualifications

• 6–10+ years of program or project management experience.
• Hands-on experience with at least one end-to-end SaMD program.
• Familiarity with FDA pathways and 21 CFR 820 Design controls.
• Experience with Quality Management Systems (QMS).

Responsibilities

• Drive execution of SaMD programs across the full product lifecycle from development to regulatory submission and launch.
• Partner with ML, Product, Engineering, Clinical, Regulatory, and Quality to deliver milestones.
• Coordinate multiple SaMD initiatives and align timelines and dependencies.
• Build and maintain detailed program plans and track progress against deliverables.
• Support design controls and regulatory documentation compliance.
• Coordinate verification, validation, clinical studies, regulatory submissions, and DHF work.
• Identify and manage risks and blockers; escalate as needed.
• Facilitate clear communication and regular program updates across stakeholders.
• Scale program management processes as the SaMD portfolio grows.

Skills

Program management

SaMD

Regulatory knowledge

QMS

Design controls

Job description

the company is an advanced health and fitness wearable on a mission to unlock human performance. We empower our members to improve their health and perform at a higher level through a deeper understanding of their bodies and daily lives.

We are looking for a Senior Program Manager, SaMD to join our growing team and help scale the execution of our Software as a Medical Device programs. This role will partner closely with an existing Program Manager and cross-functional leaders to drive the successful delivery of regulated features.

This is an execution-focused role for someone who has experience working on end-to-end SaMD programs and can operate effectively within an established but evolving system.

RESPONSIBILITIES:

• Drive execution of SaMD programs across the full product lifecycle, from development through regulatory submission and launch

• Partner with Machine Learning, Product, Engineering, Clinical, Regulatory, and Quality to plan and deliver against program milestones

• Work alongside an existing Program Manager to coordinate multiple SaMD initiatives, ensuring alignment across timelines and dependencies

• Build and maintain detailed program plans, tracking progress against key deliverables and identifying risks early

• Support development in compliance with design controls and regulatory requirements, ensuring documentation and processes are followed

• Coordinate cross-functional activities including: Verification & validation, Clinical studies, Regulatory submission preparation, Design history file (DHF) documentation

• Identify and proactively manage program risks and blockers, escalating as needed

• Facilitate clear and consistent communication across stakeholders, including regular program updates

• Help strengthen and scale program management processes as the company expands its SaMD portfolio

QUALIFICATIONS:

• 6 - 10+ years of program or project management experience

• Hands-on experience working on at least one end-to-end SaMD program (from development through regulatory submission/clearance)

• Familiarity with: FDA regulatory pathways (e.g., 510(k), De Novo), Design controls (21 CFR 820, ISO 13485) and SaMD development lifecycle

• Experience working within or closely with Quality Management Systems (QMS)

• Understanding of key standards such as: IEC 62304 & ISO 14971

• Proven ability to coordinate across Product, Engineering, Clinical, and Regulatory teams

• Strong organizational, communication, and stakeholder management skills

• Experience in wearables, digital health, or consumer health products

• Experience supporting clinical evidence generation or studies

• Experience working across multiple concurrent programs

• Background in a technical or scientific field

This role is based in the the company office located in Boston, MA. The successful candidate must be prepared to relocate if necessary to work out of the Boston, MA office.

the company is an Equal Opportunity Employer and participates in E-verify to determine employment eligibility

The the company compensation philosophy is designed to attract, motivate, and retain exceptional talent by offering competitive base salaries, meaningful equity, and consistent pay practices that reflect our mission and core values.

At the company, we view total compensation as the combination of base salary, equity, and benefits, with equity serving as a key differentiator that aligns our employees with the long-term success of the company and allows every member of our corporate team to own part of the company and share in the company’s long-term growth and success.

The U.S. base salary range for this full-time position is $155,000 - $185,000. Salary ranges are determined by role, level, and location. Within each range, individual pay is based on factors such as job-related skills, experience, performance, and relevant education or training.

In addition to the base salary, the successful candidate will also receive benefits and a generous equity package.

These ranges may be modified in the future to reflect evolving market conditions and organizational needs. While most offers will typically fall toward the starting point of the range, total compensation will depend on the candidate’s specific qualifications, expertise, and alignment with the role’s requirements.