Field Action Coordinator - Boston Scientific - Arden Hills, MN
(2025-02 - 2025-07)
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% prompt 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 prompt 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.
- Serve as the primary point of contact for internal teams, distributors, healthcare providers, and customers about 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.
- Communicate closely with engineering, manufacturing, supply chain, and customer service teams to manage product retrieval, replacement, or correction.
- Aid 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 - Fairview Health Services - Edina, MN
(2024-05 - 2024-07)
- Maintain/reconcile 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 prompt 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.
- 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
- Supports improvement, efficiency, and innovative thinking
- Successful completion of formal medical training program such as MA, HUC, NA, etc)
- Excellent public relations, communication, and prioritization skills.
- Proficient telephone and computer skills.
- Knowledge of third-party payors
- Demonstrated focus on customer service/patient service with every interaction.
- Ability to work independently, prove critical thinking skills and engage in ongoing process improvement.
- Flexible, efficient, ability to embrace change.
Program Coordinator III - Medtronic - Mounds View, MN
(2024-01 - 2024-03)
- 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)
- Help 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 find key organizational needs within the site and ease 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
- Effective 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
(2021-09 - 2023-06)
Work directly for the Director of Physicians, Director of Quality and Assurance, Director of Operation and VP of Children's Hospital
- Key facilitator for case review meetings by gathering all data to compile a presentation of key points and visual representation of the findings.
- Perform clerical tasks such as typing, preparation of documents, mailing, answer phones and make client/business associate calls
- Draft/finalize policies, procedure, protocols, guidelines, etc.
- Maintain patient records
- Perform billing tasks and compile data.
- Maintain databases and Excel spreadsheets.
- Generate reports using the Windchill app to watch 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
- Draft/finalize initial correspondence to internal customers, or to clients or business associates.
- Coordinate meetings, conferences, presentations, travel arrangements for physicians and executive.
- Maintained providers/executive's schedules, expenses, and/or education tracking (Concur).
- Used Amion and PeopleSoft to maintain OR, Call, and clinic schedule to ensure the correct hours were calculated into their pay schedule.
Medical Administrative Assistant - Mayo Clinic - Rochester, MN
(2016-06 - 2020-01)
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.
- Managed 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
- Exhibited 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.
- Accountable for ensuring accuracy and completeness through attention to detail; accuracy and thoroughness in all patient-related activities is critical.
