Regulatory Strategy Project Manager

• 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.

1. Medical Device Experience - Experience working with regulated medical devices preferably across software-based platforms with hardware experience also considered. Experience supporting the development design regulatory submission or launch of regulated health products is strongly preferred. Candidates should have a working knowledge of Design History Files (DHF) and related product documentation including requirements test plans test reports and regulatory submission package contents (e.g. DHF and technical documentation).
2. 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.
3. 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.

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