This is a hybrid opportunity where you'll work out of our Concord office 2-3 times weekly.
Summary:Responsible for managing lifecycle and portfolio operations for marketed INTERCEPT Blood System products. Works with cross-functional teams to plan and drive the implementation of approved product enhancements, claim extensions, labeling and configuration changes, regulatory submissions, and launches. Represents customer and commercial needs and coordinates execution across Product Management, Regulatory, Quality, R&D, Supply Chain, Service, Deployment, and Regional Marketing.
Primary Responsibilities:- Create and manage lifecycle project plans and activities within regional change controls:
- define milestones, dependencies, risks, owners, due dates, and status for assigned initiatives
- coordinate labeling changes, product configurations, inventory, service, training, and launch readiness
- escalate decisions involving product direction, scope, priority, investment, or major cross-functional tradeoffs to the Sr. Director
- Represent the customer and commercial perspective on development and change control teams. Communicate customer requirements, assess the commercial impact of technical or schedule constraints, and recommend practical options.
- Lead implementation and launch planning for approved products, claims, and changes.
- Develop and execute the regional plan with cross-functional partners and hand off downstream messaging, collateral, and sales-support needs to Regional Marketing.
- Support related commercial and quality activities, including tenders, customer feedback and complaints, and quality system documentation.
- To be effective in the responsibilities above, the individual will:
- develop subject matter expertise on INTERCEPT products and relevant workflows
- follow applicable regulations, including ISO 13485, and all company processes and procedures
Qualifications/Requirements/Skills:- Bachelor's degree in life sciences, medical devices, transfusion medicine, business, or a related field; MBA desirable.
- Relevant skills:
- Customer engagement, listening, and advocacy
- Problem solving and practical recommendations
- Project management, prioritization, and follow-through
- Cross-functional influence in a matrix organization
- Initiative and sound judgment when escalating issues
- Accountability for results and attention to detail
- Clear writing, effective meeting leadership, and concise presentations
- Adaptability and ability to manage multiple projects concurrently
- Effective collaboration across global functions
- Minimum of 3-5 years of relevant experience in product management or a related execution/operational role in medical devices or life sciences. Experience should include several of the following:
- Managing change controls or product lifecycle initiatives
- Supporting product requirements or cross-functional design decisions
- Coordinating regulatory, labeling, quality, or manufacturing work
- Planning product, claim, or geographic launches
- Travel estimated at 10-25%, including occasional weekends and travel.
Benefits plans: medical, dental, vision, domestic partner benefits, paid maternity and paternity leaves, healthcare and dependent care flexible spending, life and accidental death insurance, long-term and short-term disability insurance, matching 401(k), RSUs
Work and family: EAP, legal and financial services, health club membership discounts, tuition reimbursement
Compensation
: The base salary range for this position in the selected city is $121,000-$150,000 annually. Base pay is one part of the total package to compensate and recognize employees for their work.
