Sequel is re-engineering life's essential products - starting with your tampon. Founded by two Stanford engineers and athletes, Sequel relies on fluid mechanics to finally give women the leak-free menstrual experience they need to perform at their best in the boardroom, the stadium, and beyond.

We believe that women are never truly prepared for their most critical moments when their products are not up to the standards that they should be. For modern active women who are breaking barriers and shattering glass ceilings today, the current selection of women’s health products are leaky tampons or bulky liners and do not measure up to their standards.

We are looking for a Project Manager that has previous experience with medical regulatory.

The ideal candidate has experience working in a highly regulated environment, such as medical devices, aerospace, etc. An individual who would excel in this role would be a self-starter who thrives in a fast-paced, high-growth, results-oriented environment.

The Project Manager will be responsible for achieving successful implementation of manual production operations focused on passing FDA approval and successful production of our medical product. This will include being responsible for projects and managing all product and operation deliverables required to develop and deliver our medical products or therapies, including all design transfer activities. This individual will also provide direction and leadership to a cross-functional team, including members with expertise from all areas involved in product development and commercialization. The Project Manager is accountable for overall product execution and that we meet all of our team commitments and any changes or updates are communicated in a timely manner.

Experience with a QMS is required.

KEY RESPONSIBILITIES

• Leads projects with small to medium complexity to develop and commercialize our hero product.
• Develops project plans specifying goals, strategy, staffing, scheduling, identification of risks, contingency plans, and allocation of resources leveraging team inputs and strengths.
• Provides direction and leadership to cross-functional teams while directing and managing project tasks involving initiation, planning, execution, monitoring, controlling, and closing.
• Owns the creation and daily management of project schedule and critical milestones, with input from a cross-functional team.
• Assists Operations leadership with activities and initiatives as required.
• Collaborate with business and functional leaders to identify and manage risk assessment and communicate accordingly.

QUALIFICATIONS

• 5 years of related medical device experience, and experience in multi-functional business experience.
• PMP certification is preferred
• Previous Medical device operations experience is preferred