Summary
Overview
Work History
Education
Skills
Websites
Volunteer Experience
Awards
Selected Accomplishments
Timeline
Generic

Amy L. Anderson

Norton,MA

Summary

Accomplished post market surveillance professional with over 10 years of experience in the medical device field and a strong background of deep customer facing experience. Broad knowledge of global quality and compliance requirements with progressive leadership in business strategy, compliance and relationship management. Outstanding presentation and communication skills with the ability to lead teams, implement solutions and drive improvements in challenging environments. Ability to analyze the current business landscape, envisioning future scenarios and creating a roadmap to success. Logical thinker that collects relevant information, detects patterns, observes and interprets data to make sound decisions and make recommendations to leadership. Strong work ethic with expertise innovating solutions and executing quickly. Passionate about motivating and fostering a positive, supportive environment to help cultivate success.

Overview

12
12
years of professional experience

Work History

Sr. Manager, Post Market Surveillance

Draeger Medical Systems, Inc.
Andover, MA
01.2023 - Current
  • Developed and maintained strong relationships with international stakeholders traveling to Germany and Philadelphia for training, workshops and collaborations
  • Supported Patient Monitoring and Thermoregulation global complaint handling team and identifying talent for such roles
  • Assured compliance activities were met for complaints, adverse reporting and maintenance of the post market surveillance system
  • Developed job descriptions, set/monitored targets and development objectives and mentored direct reports
  • Championed development and improvements of trainings pertaining to complaint handling processes and standard operating procedures
  • Provided leadership and direction to staff
  • Conducted performance evaluations and made recommendations in support of performance ratings, salary adjustments, promotions etc
  • Participated in quality system activities and support internal and external audits
  • Actively promoted and supported the quality management system, quality objectives and quality policy
  • Knowledge of CFR 820, 803, 806, ISO 13485 and ISO 14971, as well as; Health Canada and EU MDR
  • Managed the collection, review, tracking, trending, analysis and reporting of post market to create multiple monthly reports and KPIs
  • Facilitate the presentation of monthly reports to key stakeholders
  • Monitored complaints for potential trends and escalation of information for feedback loops
  • Responsible for assisting with field actions and maintaining correction and removal documents product recall files and correspondence
  • Facilitated meeting, discussions & workshops across multiple organizations to improve/enhance complaint handling processes

Sr. Manager, Post Market Regulatory Affairs

Straumann Group
Andover, MA
01.2022 - 12.2022
  • Supported the North America complaint handling team functions in accordance with the company, FDA and Health Canada requirements while monitoring appropriate metrics to track quality/regulatory and process improvement
  • Managed recall activities in NAM with corporate and the product safety officer
  • Developed job descriptions, set/monitor targets and development objectives and mentor direct reports
  • Prepared and delivered periodic training sessions to internal groups as needed
  • Provided leadership and direction to staff
  • Conducts performance evaluations and makes recommendations in support of performance ratings, salary adjustments, promotions etc
  • Participated in quality system activities and support internal and external audits
  • Actively promoted and supported the quality management system, quality objectives and quality policy

Post Market Surveillance Manager

Nova Biomedical
Waltham, MA
01.2019 - 12.2022
  • Owned/led activities associated with complaint handling and regulatory submissions
  • These activities include intake, investigation, documentation, follow-up, regulatory reporting, complaint review and metrics for complaints received from customers
  • Managed recurring project meetings; ensures accountability across the team for deliverables
  • Contributed to the development of operational policies and procedures that affect personnel with the assigned organizational unit
  • Collaborated with quality, regulatory, medical affairs, tech support, manufacturing and operations to inform senior management of timely communication for domestic and global events
  • Ensured compliance with all appropriate laws and regulations, relevant to the job function
  • Created an environment that fosters collaborative teamwork within and across functions globally; leads, develops and mentors direct staff as well as influences and drives compliance cross-functionally through all global business and regional teams

US Medical Specialist

Integra Life Sciences
Mansfield, MA
01.2018 - 12.2019
  • Monitored daily work operations and provided direction and guidance to staff to achieve projected goals
  • Suggested/identified changes, modifications and improvements to the documentation preparation, processes, and templates to improve communication, quality, efficiency and productivity
  • Collaborated with quality, regulatory, medical affairs, tech support, manufacturing and operations to inform senior management of timely communication for domestic and global events
  • Monitored and evaluated complaints through weekly and monthly reports to ensure proper processing while maintaining on-time closure rates

Sr. Specialist, Customer Advocacy-Clinical

Cardinal Health (acquired from Medtronic)
Mansfield, MA
01.2017 - 12.2018
  • Understands US FDA regulations for Class I, II, and III medical devices regarding Medical Device Reports (MDR’s), Adverse Drug Event (ADE’s) and complaint handling reporting
  • Worked with cross functional teams to ensure proper communication and evaluation/investigation of customer issues such as manufacturing facilities, distribution centers, R & D as well as sales and marketing
  • Provided guidance and training to staff and other resources as required instruction and feedback to the group as needed to ensure completeness and consistency to maintain group goals
  • Participated in new hire training and onboarding as well as oversee outsourced contractor metrics
  • Maintained daily post market surveillance monitoring practices as well as medical devices, CAPA, MDR and ADE reporting

Post Market Surveillance Analyst II

Medtronic (acquired from Covidien)
Mansfield, MA
01.2016 - 12.2017
  • Determined reportability (MDR/ADE) of complaints to FDA and other international regulatory agencies
  • Reviewed, tracked, trended, analyzed and reported on complaint data to management as needed
  • Interfaced to gather additional information required for complaint initiation/investigations, including retrieval of product samples and or durable equipment for evaluation
  • Analyzed and entered data into the complaint management database regarding customer/patient product inquiries and complaints utilizing good documentation practices (GDP)

Post Market Surveillance Analyst I

Covidien
Mansfield, MA
01.2013 - 12.2016
  • Ensured that complaints are entered into the database from various sources (i.e
  • Email, verbal, fax, etc.)
  • Determined product and incident complaint codes based on the master symptom code severity list
  • Performed Good Faith Efforts (GFE’s) for product return and obtain required information for complaint assessment and evaluation
  • Monitored quality, completeness and timeliness of complaint investigations and files

Education

Bachelor of Arts - Sociology of Education

Bridgewater State University
Bridgewater, MA

Skills

  • Global Compliance
  • Project Management
  • Communication
  • Training
  • Problem Solving
  • Decision Making
  • Leadership
  • Initiative
  • Resilient & Empathetic
  • Relationship Building
  • Creativity
  • Flexibility
  • Integrity
  • Detail Oriented
  • Analytical
  • Results Driven
  • Time Management
  • Big Picture Individual

Volunteer Experience

  • Make-A-Wish Massachusetts and Rhode Island Wish Granter. Wish granters are essential to fulfilling each child's wish. They work in teams of two or three and help the wish child brainstorm wish ideas that could bring them hope and joy. They also help create an exceptional wish experience through ongoing engagement with the child and their family.
  • Bridgewater State University (BSU) Student Delegate for State House Day, Advocated on behalf of BSU to the legislators at the State House to gain their support for several amendments regarding public education funding in Massachusetts.
  • The Washington Center Program Democratic National Convention, Two-week seminar course examining the role of the national conventions in the nomination process and election of political party candidates. Fieldwork position with access control for the Time Warner Cable Arena. Team Captain for access control volunteer in conjunction with the DNC convention committee and Secret Service.

Awards

  • Recipient of Adrian Tinsley Program (ATP) Summer Research Grant, Conducted a study regarding the 'Food Pantry Dilemma: Understanding the need for nutritional value in emergency food provided in a down economy.' Presented the research at the Eastern Sociological Society conference in Boston, MA. This work was also presented at the National Conference on Undergraduate Research (NCUR) in March 2012, Ogden, UT. This work has been published at Bridgewater State University.
  • Alpha Kappa Delta International Sociology Honor Society Student Speaker
  • Recipient of Who’s Who Among College Students

Selected Accomplishments

Supported the effective management of issues and/or crisis by following the company’s guidelines and tools., Functioned as primary contact for Affiliates by resolving issues, providing reports, training and other requests as needed., Actively participated in relevant committees and meetings for innovation sourcing, sustainability, establishing relevant linkages between collaboration projects, and present projects at relevant management meetings., Averted critical customer loss of 4.5 million in sales., Successful track record in developing business to business relationships at a senior level with evidence of results., Collaborated with international teams in generating global articulate training., Generated onboarding material for new hires.

Timeline

Sr. Manager, Post Market Surveillance

Draeger Medical Systems, Inc.
01.2023 - Current

Sr. Manager, Post Market Regulatory Affairs

Straumann Group
01.2022 - 12.2022

Post Market Surveillance Manager

Nova Biomedical
01.2019 - 12.2022

US Medical Specialist

Integra Life Sciences
01.2018 - 12.2019

Sr. Specialist, Customer Advocacy-Clinical

Cardinal Health (acquired from Medtronic)
01.2017 - 12.2018

Post Market Surveillance Analyst II

Medtronic (acquired from Covidien)
01.2016 - 12.2017

Post Market Surveillance Analyst I

Covidien
01.2013 - 12.2016

Bachelor of Arts - Sociology of Education

Bridgewater State University
Amy L. Anderson