Regulatory Strategy Project Manager

KEY SUCCESS FACTORS (Top 3 Must-Have Skills): 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. Soft Skills: 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.

Regulatory Strategy Project Manager
Location: Cupertino, CA (Hybrid)

ABOUT THIS FEATURED OPPORTUNITY
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.

THE OPPORTUNITY FOR YOU
The Project Manager will support up to 3 disclosed projects focused on new health and medical features. Examples of features include Sleep Apnea Notifications on Apple Watch, Hypertension Notifications, and AirPods Pro hearing-related features.
This role will focus heavily on market release strategy and timelines, helping teams understand when a new feature can launch in a specific market and what regulatory, development, design, and operational milestones must be completed along the way.

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.

KEY SUCCESS FACTORS (Top 3 Must-Have Skills):

1. 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. Candidates should have experience working in a regulated environment and managing cross-functional timelines, milestones, and dependencies.
2. Medical Device Experience 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.
3. Regulatory / Medical Device Knowledge 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. Familiarity with regulatory requirements across international markets such as India, China, and South Korea is a plus.

NICE TO HAVES:

1 . Soft Skills: 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.


About INSPYR Solutions
Technology is our focus and quality is our commitment. As a national expert in delivering flexible technology and talent solutions, we strategically align industry and technical expertise with our clients' business objectives and cultural needs. Our solutions are tailored to each client and include a wide variety of professional services, project, and talent solutions. By always striving for excellence and focusing on the human aspect of our business, we work seamlessly with our talent and clients to match the right solutions to the right opportunities. Learn more about us at inspyrsolutions.com.

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