Bill Rate ***-*** on site Position Summary
The 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.
The successful candidate will 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. This individual will work effectively within a matrix organization, providing project leadership, risk management, planning, and communication to support regulatory compliance objectives and continued market access.
Experience working in a regulated medical device, in vitro diagnostics (IVD), biotechnology, or life sciences environment is highly desirable.
Job Responsibilities
- Lead cross-functional technical dossier audit projects supporting regulatory re-registration and product sustainment initiatives.
- Develop and maintain integrated project plans, timelines, milestones, and progress tracking mechanisms.
- Coordinate reviews of technical documentation, including design history files, verification and validation documentation, risk management files, labeling, and other regulatory deliverables.
- Partner with Regulatory Affairs, R&D, Quality, Medical Affairs, Manufacturing, and Marketing to assess documentation readiness for regulatory submissions.
- Facilitate gap assessments to identify missing, outdated, incomplete, or non-compliant documentation.
- Drive development and execution of remediation plans to address identified gaps and ensure submission readiness.
- Manage project risks, dependencies, and issues through proactive planning and escalation when needed.
- Schedule, organize, and facilitate team meetings, reviews, and working sessions.
- Record and publish meeting minutes, decisions, action items, and key project updates.
- Monitor progress against project milestones and follow up with functional owners to ensure timely completion of deliverables.
- Maintain accurate project documentation, dashboards, and status reports for leadership and stakeholders.
- Communicate project status, risks, mitigation plans, and key decisions to cross-functional leadership teams.
- Ensure project activities are conducted in compliance with applicable quality systems, design control requirements, and regulatory expectations.
- Support continuous improvement initiatives related to technical documentation processes, regulatory readiness, and project execution.
- Apply project management best practices and tools to drive alignment, accountability, and project success.
Minimum Qualifications
Education and Experience
- 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.
Knowledge, Skills, and Abilities
- Strong project planning, organization, and execution skills.
- Ability to manage multiple projects and priorities simultaneously.
- Excellent meeting facilitation, written communication, and presentation skills.
- Strong analytical, problem-solving, and risk management capabilities.
- Demonstrated ability to influence and drive accountability in a matrix organization.
- Proven ability to track and manage action items, dependencies, and project deliverables.
- Detail-oriented with a commitment to quality and compliance.
- Proficient with Microsoft Office applications including Excel, PowerPoint, Word, and Project.
- Experience with project management, document management, or product lifecycle management tools is preferred.
- Demonstrated ability to effectively communicate with technical, regulatory, and business stakeholders.
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EEO:
Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.