Regulatory Compliance Project Management

Matthew Angerer **************.***@*****.*** **** Devonshire Dr.

562-***-**** linkedin.com/in/matthew-angerer Corona, CA 92879 nexxt.com/p/MatthewAngerer

EXECUTIVE SUMMARY

Talented Medical Device Professional with 7 years’ experience in the medical device and pharmaceutical industries developing processes for regulatory compliance, new product component introduction, cost savings and improved execution performance using Project Management and Engineering principles. Strategic thinker with a keen eye for the big picture. Consistently identifies opportunities, analyzes data, and makes sound decisions that align with business objectives using critical thinking and problem-solving skills. Skilled at decision-making, capable of prioritizing tasks, balancing competing demands, and making timely choices, even in the face of uncertainty. Drives innovation through team collaboration and enthusiasm. Seasoned leader with a proven ability to navigate complex organizational landscapes. Excels at influencing and inspiring others, driving positive change, and achieving exceptional results. Agile manager who thrives in diverse environments, builds strong relationships, fosters open communication, and works effectively with individuals at every level. Strengths include project planning and execution, adaptive change control, recognition of future problems well in advance, team leadership, and proactivity. Expert in creating value in regulatory, quality, and scientific systems. My primary goals are excellence in personal performance as well as those who work with me, and consistent quality of goods or services produced.

SKILLS

Management Quality Technical

●Project management ● Change analysis ●Technical writing

●Equipment commissioning ● Quality Assurance ● Bench chemistry

●Product Lifecycle Management ● Gap Analysis ● Multiple language proofing

●Strategy and Negotiations ● Change control ● Construction tradesmanship

●Proof of Principle ● Statistical analysis ● Troubleshooting

●Innovation ● Attention to detail ● Knowledgeable in the following

●Problem solving ● Develop Sampling Plans Regulations:

●PMBOK 6th & 7th edition ● Document control ISO 9000, ISO 9001,

●Risk Management ● Comparative analysis ISO 13485, ISO 17025

●Procurement & invoicing ● EDMS EU MDR 2017/745

PROFESSIONAL EXPERIENCE

Technical Consultant at Howmet Fastenening Systems - Engineering department February 2025 – Present

- Contracted through Apidel

●Consolidation of Process Control Documents for thousands of products for exclusive aerospace client.

●Review existing files and consult with Engineers to become knowledgeable in all client products and processes.

●Quality check information in files or build new ones where needed.

●Aggregate information of processes into Excel file.

●Group similar process structures together and create simplified Process Flow Diagram.

●Create detailed Process Flow Diagrams grouping several dozen products into 4 or fewer Process Flows.

●Report on weekly progress to Regional Engineering Manager.

Engineer Process Lead (Labeling Team) at Johnson & Johnson Surgical Vision August 2021 – June 2024

- Contracted through Kelly OCG

●Ensured strict adherence to labeling compliance regulations in all stages of product development.

●Optimized processes by identifying inefficiencies, proposing and implementing streamlined solutions.

●Collaborated with cross-functional teams and other stakeholders to achieve project goals.

●Managed multiple Labeling projects simultaneously using PLM EDMS (Oracle Agile), ensuring timely completion and successful outcomes.

●Top performer in updating product labels and inserts for dozens of products through PDMS to comply with EUMDR 2017/745 regulations

●Document creation and editing (SOPs, Work Instructions, IFUs, CPLs)

●Create operational procedure content based on Regulatory assessments.

●Independently review, evaluate and recommend changes of team proposed Change Orders (COs), Temporary Change Orders (TCOs), Engineering Change Orders (ECOs), Engineering Change Requests (ECRs) and Manufacturing Change Orders (MCOs) for Regulatory compliance, and in accordance with regulatory and business standards.

●Monitor and/or escalate issues regarding the change processing status to meet project plan release deadlines.

●Organize and conduct meetings to bridge disconnects between stakeholders

●Create change orders for redline changes. End-to-end accountability to process COs, CRs, ECRs, ECOs, MCOs & TCOs.

●Procure translation services, conduct multi-language QA proofing & complete invoicing.

●Report Risk Management assessments and offer strategic solutions.

●Investigate and clarify invoicing on-line portal glitch

Project Manager at B Braun Medical June 4, 2020 – March 11, 2021 - Contracted through Manpower Engineering

●Results based decision making position.

●Investigate to identify & solve international inspection criteria alignment and harmonization issues at production stand-still. Initiate steps to implement new process.

●Conduct SAT for R&D equipment commissioning using Installation and Operation Qualifications (IQ/OQ) .

●Computer systems security upgrades.

●Change control management & coordination for R&D Product Development engineering designs

●Compiles and/or produces all required documents for presentation to change control review board for change approvals.

Technical Writer at Abbott Diagnostics Manufacturing Department Nov 1,2019 - March 9, 2020

- Contracted through TalentBurst

●Collaboration with Subject Matter Experts, Department Managers and Quality Assurance department in the creation and updating of SOP’s.

●Redline of all Label Masters.

●Assist with Audits.

●Utilized strong editing skills to ensure accuracy and clarity of written documents.

●Demonstrated technical writing proficiency in creating user-friendly guides and manuals.

●Crafted various documents such as reports, proposals, and presentations.

●Applied strong research abilities to gather data and information for project development.

Additional experience

●3 years in Change Analysis and Documentation control

●3 years as chemist (analytical and pharmaceutical production)

●12 years in construction (carpentry, masonry, plumbing)

●1 year wax mold injection & heat treating

EDUCATION

Cal State Long Beach - Bachelor of Science in Chemical and Environmental Engineering. Aug 2009 – May 2014

Long Beach City College - Associate of Arts degrees in both biology and physical science. Aug 2006 – Aug 2009

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