Regulatory Strategy Project Manager

INSPYR Solutions • Cupertino, CA

1d • Hybrid

About The Position

The team is expanding and launching new health features in the medical device space, creating a need for additional project management support across several disclosed initiatives. This role will support the development and market release of innovative health features across both software and hardware platforms. The ideal candidate has experience working in regulated environments and understands the complexities involved in bringing medical device products and features to market.

Requirements

• 2+ years of Project Management experience – Experience managing market release timelines for new products, new product introductions, or new features, preferably on the development or design side.
• Experience working in a regulated environment and managing cross-functional timelines, milestones, and dependencies.
• Experience working with medical devices, preferably across software (preferred) or hardware platforms.
• Experience supporting the development or launch of regulated health products is strongly preferred.
• Ability to speak the language of regulatory and medical device organizations and understand common regulatory terminology and requirements, including ISO 13485, EU MDR, and 21 CFR .

Nice To Haves

• Familiarity with regulatory requirements across international markets such as India, China, and South Korea is a plus.
• Someone who is motivated, willing to learn, learns from mistakes, handles ambiguity well, and is comfortable taking risks or approaching problems in non-traditional ways while being able to clearly explain the logic behind their decisions.

Responsibilities

• Own and manage market release timelines for new health and medical device features.
• Partner with cross-functional teams to determine key milestones required to bring new features to market.
• Support strategic decisions around which markets a new feature can launch in and when.
• Track major development, design, regulatory, and market-readiness milestones.
• Identify dependencies, risks, and potential timeline impacts across hardware and software workstreams.
• Partner with regulatory, engineering, design, product, and other stakeholders to ensure market-release plans remain on track.
• Help translate regulatory and medical device requirements into actionable project timelines and deliverables.
• Manage ambiguity and changing priorities across multiple high-visibility projects.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: No Education Listed