Role OverviewThe Project Manager will lead cross-functional initiatives focused on technical dossier audits and regulatory readiness activities for in-market clinical diagnostic products. This role will partner closely with Regulatory Affairs, R&D, Quality, Marketing, Medical Affairs, and other stakeholders to assess the completeness and compliance of technical documentation required to support global product registrations, re-registrations, and regulatory submissions.
What You Will Do
Coordinate the systematic review of technical files and supporting design documentation, facilitate identification of compliance gaps, develop remediation plans with subject matter experts, and drive execution to ensure products meet applicable regulatory requirements.
Why It Might Be a Fit
Experience working in a regulated medical device, in vitro diagnostics (IVD), biotechnology, or life sciences environment is highly desirable.
Requirements
- Bachelor's degree in a scientific, engineering, regulatory, or related discipline.
- Minimum of 3-5 years of experience in project management within a regulated industry.
- Experience working in medical devices, in vitro diagnostics (IVD), biotechnology, life sciences, or related regulated environments.
- Demonstrated experience leading cross-functional initiatives involving multiple stakeholders and competing priorities.
- Working knowledge of product development documentation, design controls, quality systems, and regulatory submission processes.
- Experience coordinating complex projects involving documentation review, compliance assessments, or remediation activities preferred.
- Familiarity with global regulatory frameworks applicable to medical devices and IVD products is preferred.
- Experience supporting regulatory submissions, product registrations, or compliance programs is a plus.
- Project Management Professional (PMP) certification is a plus but not required.
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