Project Manager Compliance Specialist

COLLEEN HULSHOF

Raleigh, ***** NC

**********@*****.***

PROFESSIONAL SUMMARY

Accomplished professional with expertise in compliance and stakeholder collaboration within the medical device industry. Skilled in Scrum and Waterfall methodologies, achieving a 125% increase in project scope completion. Developed tracking systems and dashboards, reducing costs by 22% and improving on-time deliveries by 33%. Designed and implemented educational programs, enhancing training standards and engagement. Strong communicator, aligning project goals with organizational objectives and driving team performance. Expert in optimizing workflows for operational excellence and measurable results. Extensive experience in managing complex approval processes, customer/vendor management, and streamlining operations. Skilled in coordinating cross functional teams to ensure regulatory compliance and operational efficiency. Familiar with medical device production flows and adept at working with design, prototyping, validation, customers and manufacturing teams on capital equipment projects.

SKILLS

Project Management

Compliance and Regulatory Oversight

Data Analysis and KPI Tracking

Supply Chain Optimization

Collaboration

Problem-Solving

Fast-Paced Doer

Team Leadership

Cross Functional Collaboration

Adaptability

Communication

Capital Management

Budget and Cost Management

Attention to Detail

Compliance Management

Process Improvement

Regulatory Knowledge

Vendor Management

PROJECT LIST

Medical, Legal, Regulatory Compliance Asset Compliance Project

Ocular Surface Disease HCP Project

Simulated Cataract Surgery Gaming Project

COE HCP Project

Patient/HCP Engagement Project

Resident Networking & Surgical Program to include Capital Management

PROFESSIONAL EXPERIENCE

Project Manager, Compliance / Johnson & Johnson - Irvine, CA 04/2022 - 11/2024

Spearheaded daily operations of the copy approval process for education and marketing teams using Scrum methodology, enhancing flexibility and structure while driving efficiency.

Collaborated cross-functionally with content authors, regulatory, legal, and healthcare compliance reviewers to ensure seamless workflows, achieving a 125% improvement in scope completion rates.

Designed and implemented a project tracking system with automated notifications and an intuitive dashboard, accelerating timelines and optimizing productivity across teams.

Produced a high-impact explainer video detailing the promotional review process, effectively engaging senior leadership and fostering alignment on compliance priorities.

Project Manager, Professional Education / Johnson & Johnson - Irvine, CA 03/2020 - 03/2022

Collaborated with stakeholders to design and implement high-impact educational programs, aligning with multiple organizations' strategic objectives and achieving measurable improvements in training outcomes.

Leveraged phase-based waterfall methodology to assess requirements, manage scope creep, and execute complex initiatives, including the development of a national surgical preceptorship program and ophthalmic surgery software platform.

Increased engagement at trade shows and Johnson & Johnson-sponsored events by launching innovative training programs, elevating attendance rates among Resident Doctors and setting new industry standards.

Owned and drove customers onboarding projects for ophthalmic surgeons, ensuring they progressed through each phase successfully. Additionally, engaged effectively with multiple customer stakeholders on both technical and business topics.

Conducted regular progress updates and facilitated User Acceptance Testing (UAT) for a virtual training platform, ensuring stakeholder satisfaction and timely project delivery.

Project Manager, Logistics & Sales Training / Johnson & Johnson - Santa Ana, CA 03/2018 - 02/2020

Strategically assessed and delivered tailored solutions for surgical lab events nationwide, managing budgets, timelines, and reporting to ensure seamless execution.

Delivered Capital Equipment across the U.S. for surgical events.

Utilized waterfall methodology and Microsoft Office 365 tools to track and measure key performance indicators (KPIs), enhancing operational efficiency and decision-making.

Optimized supply chain processes by analyzing metrics and switching carriers, achieving a 20% cost reduction and a 33% improvement in on-time deliveries.

Designed and implemented a home lab infrastructure, reducing surgical wet lab event packing and loading times by 35% and lowering overall lab costs by 22%.

In conjunction with Learning and Development, designed and implemented a structured onboarding training program tailored to new Account Executives, Medical Affairs Representatives, and Customer Service Representatives.

Project Coordinator, Supply Chain / ABBOTT MEDICAL OPTICS - Santa Ana, CA 10/2014 - 10/2017

Successfully integrated into Johnson & Johnson through strategic acquisition, aligning organizational goals with J&J's standards and objectives.

Collaborated with stakeholders across two locations to develop and implement optimized delivery schedules, consistently exceeding customer expectations and service-level agreements (SLAs).

Leveraged strategic planning to streamline operational processes, ensuring seamless alignment with J&J's corporate structure and best practices.

Enhanced customer satisfaction and operational efficiency by delivering measurable improvements in service delivery and stakeholder engagement post-acquisition.

Project Coordinator R&D / ABBOTT MEDICAL OPTICS - Santa Ana, CA 09/2007 - 09/2014

Successfully transitioned into Johnson & Johnson through acquisition, aligning project management processes with J&J's operational standards and strategic objectives.

Coordinated complex project schedules for testing environments and equipment, ensuring precision and adherence to timelines to meet critical milestones.

Managed and tracked Bill of Materials (BOM) alongside lead engineers, driving accuracy and efficiency in project execution.

Established streamlined communication frameworks to keep engineers informed on test schedules, deliverables, and objectives, fostering collaboration and ensuring successful project outcomes in the validation process.

EDUCATION

Master of Arts: Adult Education & Training

University of Phoenix - Costa Mesa, CA

GPA: 3.8

Bachelor of Science: Business Management

University of Phoenix - Costa Mesa, CA

GPA: 4.0

Certified Project Manager

Association for Talent Development

Est. March 2023

WEBSITES, PORTFOLIOS, PROFILES

Colleen Hulshof LinkedIn Profile

VOLUNTEER EXPERIENCE

Volunteer Soccer Coach, 01/01/12 - 06/01/18

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