- Company Name
- TalentSphere Staffing Solutions
- Job Title
- Program Manager - IVD
- Job Description
-
**Job Title:** Program Manager – IVD
**Role Summary:**
Strategic program manager responsible for end‑to‑end delivery of in‑vitro diagnostics product programs. Leads cross‑functional teams (R&D, Regulatory, Quality, Commercial) to develop, launch, and sustain products in a regulated, fast‑paced environment, ensuring compliance, risk mitigation, and achievement of key performance indicators.
**Expectations:**
- Drive product outcomes on schedule, scope, and impact.
- Align and lead multidisciplinary teams with clear accountability.
- Maintain regulatory compliance (ISO 13485, GMP, FDA, Health Canada).
- Communicate status and decisions effectively to all stakeholder levels, including executives.
**Key Responsibilities:**
- Own program lifecycle from concept through post‑market.
- Develop and execute strategic roadmaps and resource plans.
- Coordinate cross‑functional execution, aligning goals, timelines, and budgets.
- Identify, assess, and mitigate risks, issues, and dependencies.
- Track and report KPIs; implement continuous improvement initiatives.
- Ensure adherence to regulatory standards and quality systems.
- Utilize project management tools (Wrike, MS Project, ERP/PLM) for planning and execution.
**Required Skills:**
- Proven program/product management in diagnostics, medical devices, or life sciences (5+ years).
- Strong strategic and business acumen; ability to translate vision into actionable plans.
- Expert stakeholder alignment, risk management, and KPI tracking.
- Excellent written and verbal communication; executive‑level presentation skills.
- Proficiency with Wrike, MS Project, and ERP/PLM systems.
- Familiarity with ISO 13485, GMP, FDA, and Health Canada regulations.
**Required Education & Certifications:**
- Bachelor’s degree in life sciences, engineering, or business (Master’s degree preferred).
- PMP or PgMP certification preferred.