Regulatory-Compliance Field Action Coordinator

LUKE WAGNER

CONTACT:

Email: ****.************@*****.***

Phone: 952-***-****

Address: Burnsville, MN, USA, 55337

Social links, website: https://www.linkedin.com/in/luke-wagner-6687628a

EDUCATION:

University of Minnesota – Twin Cities

September 2010 – May 2014

Bachelor of Arts in Anthropology

Division 1 Lacrosse Player

Anthropology Club Member

Rochester Community and Technical College

January 2020 - December 2021 (Not-completed)

Associate in Nursing

2019 Neva & Rachel Kuhen Scholarship

Eastview High School

September 2006 – June 2010

4.0 GPA w/Honors

6x letter winner

WORK EXPERIENCE:

Field Action Coordinator – Boston Scientific

Arden Hills, MN

February 2025 to July 2025

Coordinated cross-functional teams to ensure seamless execution of field corrective actions, maintaining compliance with regulatory requirements and minimizing disruption to product availability.

Monitored and analyzed field corrective action effectiveness by tracking completion rates across 25+ global sites, achieving a 98% timely closure rate and reducing compliance risk using Salesforce and SAP ERP systems over a 12-month period.

Coordinate and execute field actions such as product recalls, corrections, removals, and safety notifications.

Develop and implement action plans to ensure timely execution of corrective actions in compliance with FDA, EU MDR, and other global regulatory requirements.

Maintain detailed records of all field actions, including tracking progress, follow-ups, and closure documentation.

Prepare and submit regulatory reports related to field actions, ensuring alignment with global regulatory standards e.g., FDA 21 CFR 806, EU MDR, ISO 13485.

Maintain up to date knowledge of global regulatory requirements related to medical device field actions.

Collaborate with the Regulatory Affairs and Quality Assurance teams to ensure compliance with internal and external audit requirements.

Customer & Stakeholder Communication - Serve as the primary point of contact for internal teams, distributors, healthcare providers, and customers regarding field actions.

Develop customer communication materials, including safety alerts, recall notifications, and response instructions.

Coordinate responses to customer inquiries related to field actions and ensure proper documentation.

Cross-Functional Collaboration - communicates closely with engineering, manufacturing, supply chain, and customer service teams to manage product retrieval, replacement, or correction.

Assist in root cause analysis and corrective/preventive action (CAPA) implementation in collaboration with Quality and Engineering teams.

Support post-market surveillance activities and provide insights to improve product safety and compliance.

Streamlined cross-functional workflows by centralizing field action data and automating report generation, driving faster regulatory submissions and enhancing audit readiness.

Team Coordinator – Farview Health Services

Edina, MN

May 2024 to July 2024

Manage patient records

Create/maintain provider schedules for assigned areas

Complete patient registration and check-in process.

Verifies patient demographic/employer and insurance information.

Performs telephone message taking and directs communication in a timely and professional fashion

Complete records on data intake, incoming and outgoing calls, and research done within the company

Manage multiple technology applications

Manages MyChart requests including patient sign-up, responding to patient messages and multitasking prioritize appropriately

Continuously improve work processes, environment, and the overall experience to serve customers and meet business goals.

Other duties as assigned.

Organization Expectations, as applicable

Ability to provide care or service adjusting approaches to reflect developmental level and cultural differences of population served.

Communicates respectively and ensures a safe, secure environment

Provides patient education based on an assessment of the learning needs of patient/care giver

Fulfills all organizational and learning requirements relevant to the role

Supports improvement, efficiency, and innovative thinking

Successful completion of formal medical training program such as MA, HUC, NA, or Medical Secretary,

Excellent public relations, communication, and prioritization skills.

Proficient telephone and computer skills.

Flexible, efficient, ability to embrace change.

Knowledge of third-party payors is preferred.

Knowledge of medical terminology and abbreviations is preferred.

Demonstrated focus on customer service/patient service with every interaction.

Must be flexible to work various shifts and locations as required.

Ability to work independently, demonstrate critical thinking skills and engage in ongoing process improvement.

Program Coordinator III – Medtronic

Mounds View, MN

January 2024 to March 2024

Coordinate meetings/conferences for our heart value products to hospitals and attending physicians across the US

Open payment reporting and reconciling complex expense reports (Concur)

Assist meeting planners with travel, lodging, food expenses, and equipment needs.

Assures alignment and close collaboration with other local functional structures such as finance, regulatory, quality, compliance, and legal.

Facilitates in local medical device registration in cooperation with the Regulatory Department.

Assures alignment with Regional Market Development strategy.

Gather and analyze data and trends to determine key organizational needs within the site and facilitate decision-making with proactive solutions that solve these needs.

Communicate findings and solutions through established operating mechanisms.

Utilized the Windchill app to help control, content, creation, collaboration, management, and publishing processes as it relates to marketing and sales teams.

Exceptional organizational skills, allowing for effective management of multiple priorities and deadlines

Demonstrated ability to streamline office operations and enhance efficiency through process improvements

Strong communication skills, enabling clear interaction with team members and external stakeholders

Skilled in scheduling and coordinating meetings, travel arrangements, and event planning

Experienced in maintaining confidential information and handling sensitive documents with discretion

Proficient in a variety of office software, including Microsoft Office Suite and project management tools

Dedicated to fostering a positive work environment by supporting team collaboration and providing exceptional service.

Senior Administrative Assistant – Allina Health (The Mother Baby Center)

Minneapolis, MN

September 2021 to June 2023

Perform clerical tasks

Complete tasks such as typing, preparation of documents, mailing.

Answer phones and make client/business associate calls.

Maintain patient records.

Perform billing tasks and compile data.

Maintain databases and Excel spreadsheets.

Generate reports using the Windchill app to monitor and have product information readily available for patients and health services (home health care, social workers, etc.) for their breast pump products including product maintenance and software updates.

Provide department support

May schedule patient/client visits.

May perform receptionist and check-in function.

May order supplies.

May coordinate meetings, conferences, presentations, travel arrangements.

May have responsibility for assigned projects.

May manage employee and leader schedules and calendars.

May write correspondence to internal customers, or to clients or business associates.

May manage provider schedules, expenses and/or education tracking (Concur) .

May manage department timecards.

Used the systems of Amion and PeopleSoft to maintain OR, Call, and clinic schedule to ensure the correct hours were calculated into their pay schedule.

May manage department website.

Know where we are going as an organization and use sound judgement and critical thinking to make good decisions that support our mission.

Medical Administrative Assistant – Mayo Clinic

Rochester, MN

June 2016 to January 2020

Applies expertise to perform a variety of clinical and non-clinical administrative support tasks including requesting and managing the flow of patient records; coordinating appointment schedules; scheduling, coordination, and follow-up tasks for meetings, events, and professional travel; managing calendars; preparing documents and presentation materials; processing invoices and reimbursements; composing and/or transcribing correspondence/documents; supporting departmental projects/activities; creating and maintaining web sites, web pages, databases, spreadsheets, social media accounts; answering telephones and providing related follow-through.

Extensive use of Concur to reimburse invoices and travel arrangements air/ground transportation, lodging/hotel, meals, catering, decorum, licenses, registration fees, dues, CME credits, and personal expenses

Supports the health care provider by anticipating and responding to provider and patient needs and requests of the health care team and serves as a direct contact and resource to the patient

Was an administrator for our Fellowship and Residency Program.

Set up interviews with consultants to evaluate which candidates would be selected for the program.

Had to obtain medical degrees, credentials, boards results, DEA number and NPI number.

Provided them with onboarding which included badging travel between campuses, and location of the OR and Clinic areas.

Would manage HCP’s clinic, OR Call.

Lab, and CME schedules along with their personal calendars for meetings.

Designed the website for Division of Plastic Surgery including the public Mayo Clinic page and Mayo Clinic's intranet page using the software call WordPress

Exhibits initiative, proficiency, and adaptability to optimize the time of those supported.

Strong organizational, communication, and interpersonal skills a commitment to quality and excellence in service; confidentiality and professionalism are important components of the role.

Is accountable for ensuring accuracy and completeness through attention to detail; accuracy and thoroughness in all patient-related activities is critical.

Utilized Windchill apps for monitoring orthotics and artificial limbs to provide to third - party vendors such as Stryker and Limb Labs.

Made the process easier to reorder items for patients whether they were upgrading to new products or replacing the product they currently were using.

Also used Windchill to keep records of patient measurements and products used (Allergan) for their breast implants.

This was very helpful recently when research conducted tests on certain breast implants causing BIA-ALCL which is a form of cancer.

This allowed us to track down patient with this specific breast implant and offer them the option to have their implant replaced for free due to recent trials.

Streamlined patient information tracking and coordinated with third-party vendors using Windchill applications, ensuring timely delivery and accurate documentation of orthotic and prosthetic products

Customer Service Representative – Towers Watson

Bloomington, MN

September 2014 to November 2015

Perform customer service support by responding professionally to customer inquiries/issues received via phone, e-mail or other communication devices and ensure that appropriate action is taken.

Research participant questions related to employee health and pension benefits

Talking on the phone with clients 80% of the workday.

Must have excellent communication skills.

Have knowledge with health carrier's coverage and plan options.

Provide technical support and assist customers in using web-based, employee.

SKILLS

Medical Terminology

Organization, Communication, Scheduling-Coordination, Documentation, Time Management, Problem Solving, Confidentiality, Support, Multitasking, Technical, Planning, and Adaptability

Communication & Interpersonal Skills

Clear and professional communicator, both verbal and written.

Skilled in active listening, diplomacy, and serving as liaison between staff and leadership.

Experienced in negotiation and managing vendor relationships.

Technical & Software Proficiency

Advanced proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook).

Strong database management skills for organizing and tracking information.

Experienced with administrative and project management software tools.

Organizational & Time Management

Highly organized with the ability to manage multiple priorities simultaneously.

Strong time management skills to meet deadlines and ensure smooth operations.

Proven success in balancing competing tasks and responsibilities.

Problem-Solving & Analytical Skills

Skilled in identifying issues, analyzing data, and implementing effective solutions.

Strong critical thinking for sound decision-making.

Experienced in leading change management initiatives to improve productivity with extensive experience in streamlining healthcare operations and enhancing administrative efficiency.

Proficient in managing schedules, coordinating meetings, and facilitating communication between executives and staff.

Skilled in leveraging technology to improve workflows and maintain accurate records within a fast-paced environment.

Committed to supporting strategic initiatives that drive quality of services and operational excellence.

Contact this candidate