Ashley Miller, RAC-Devices
Director of Regulatory Affairs at Digital Diagnostics- Claim this Profile
Click to upgrade to our gold package
for the full feature experience.
Topline Score
Bio
Andrew Stawarz, PMP
I was very fortunate to work with Ashley on many initiatives during my time at Digital Diagnostics. Ashley is a go-to expert on all things regulatory, and brings an impressive amount of knowledge on FDA, submissions, compliance, audits, international markets; you name it. During countless team discussions, Ashley’s invaluable perspective was leveraged to guide key project decisions. I always admired Ashley’s approachability and willingness to be a resource, no matter how big or small the task which ranged from crafting regulatory filings, communicating with the FDA, and leading audits to providing input on a variety of highly-specific questions. Ashley is an exemplar team player, and any company would be lucky to have her.
Andrew Stawarz, PMP
I was very fortunate to work with Ashley on many initiatives during my time at Digital Diagnostics. Ashley is a go-to expert on all things regulatory, and brings an impressive amount of knowledge on FDA, submissions, compliance, audits, international markets; you name it. During countless team discussions, Ashley’s invaluable perspective was leveraged to guide key project decisions. I always admired Ashley’s approachability and willingness to be a resource, no matter how big or small the task which ranged from crafting regulatory filings, communicating with the FDA, and leading audits to providing input on a variety of highly-specific questions. Ashley is an exemplar team player, and any company would be lucky to have her.
Andrew Stawarz, PMP
I was very fortunate to work with Ashley on many initiatives during my time at Digital Diagnostics. Ashley is a go-to expert on all things regulatory, and brings an impressive amount of knowledge on FDA, submissions, compliance, audits, international markets; you name it. During countless team discussions, Ashley’s invaluable perspective was leveraged to guide key project decisions. I always admired Ashley’s approachability and willingness to be a resource, no matter how big or small the task which ranged from crafting regulatory filings, communicating with the FDA, and leading audits to providing input on a variety of highly-specific questions. Ashley is an exemplar team player, and any company would be lucky to have her.
Andrew Stawarz, PMP
I was very fortunate to work with Ashley on many initiatives during my time at Digital Diagnostics. Ashley is a go-to expert on all things regulatory, and brings an impressive amount of knowledge on FDA, submissions, compliance, audits, international markets; you name it. During countless team discussions, Ashley’s invaluable perspective was leveraged to guide key project decisions. I always admired Ashley’s approachability and willingness to be a resource, no matter how big or small the task which ranged from crafting regulatory filings, communicating with the FDA, and leading audits to providing input on a variety of highly-specific questions. Ashley is an exemplar team player, and any company would be lucky to have her.
Credentials
-
RAC-DEVICES
Regulatory Affairs Certification ProgramSep, 2020- Nov, 2024
Experience
-
Digital Diagnostics
-
United States
-
Medical Equipment Manufacturing
-
1 - 100 Employee
-
Director of Regulatory Affairs
-
Sep 2021 - Present
- Lead regulatory department in setting long-term regulatory strategies, presenting them to executive leadership, and owning final regulatory decisions. - Lead and develop regulatory submission documents for FDA, Notified Bodies, and other regulatory agencies, including responses to questions or deficiency letters. - Manage regulatory project plans against planned timelines and budgets; work with executive leadership to determine future plans. - Leads meetings with regulators… Show more - Lead regulatory department in setting long-term regulatory strategies, presenting them to executive leadership, and owning final regulatory decisions. - Lead and develop regulatory submission documents for FDA, Notified Bodies, and other regulatory agencies, including responses to questions or deficiency letters. - Manage regulatory project plans against planned timelines and budgets; work with executive leadership to determine future plans. - Leads meetings with regulators, including FDA Q-submission meetings. - Independently manage regulatory-related processes and procedures.
-
-
Regulatory Affairs Manager
-
Apr 2020 - Sep 2021
- Manage new jurisdiction regulatory product registrations, licensing requirements, and required documentation. - Develop submission documents for FDA, Notified Bodies, and other regulatory agencies; develop responses to questions or deficiency letters from regulatory agencies. - Manage 3rd party regulatory consultants. - Conduct gap analyses in anticipation of regulatory changes and implement action as necessary. - Assess regulatory impact of post-market changes on labeling… Show more - Manage new jurisdiction regulatory product registrations, licensing requirements, and required documentation. - Develop submission documents for FDA, Notified Bodies, and other regulatory agencies; develop responses to questions or deficiency letters from regulatory agencies. - Manage 3rd party regulatory consultants. - Conduct gap analyses in anticipation of regulatory changes and implement action as necessary. - Assess regulatory impact of post-market changes on labeling, design, or manufacturing process changes.
-
-
-
ICU Medical
-
United States
-
Medical Equipment Manufacturing
-
700 & Above Employee
-
Manager, Global Regulatory Affairs
-
Jul 2019 - Apr 2020
- Develop and execute global regulatory strategies and plans to ensure that new infusion systems products (including infusion pump and software) and changes to existing products are developed in accordance with global regulatory requirements. - Analyze risk versus benefit in regulatory strategies to ensure successful review by global regulatory authorities. - Act as Global Regulatory Affairs Lead within cross-functional product development teams by communicating regulatory strategies and… Show more - Develop and execute global regulatory strategies and plans to ensure that new infusion systems products (including infusion pump and software) and changes to existing products are developed in accordance with global regulatory requirements. - Analyze risk versus benefit in regulatory strategies to ensure successful review by global regulatory authorities. - Act as Global Regulatory Affairs Lead within cross-functional product development teams by communicating regulatory strategies and requirements, and ensuring requirements are incorporated into program deliverables. - Manage the preparation of global regulatory dossiers and responses to requests for additional information. - Act as point person for regulatory agency interactions (either written or oral), including the preparation of briefing packages and strategy for meetings, inspections, and responses to agency letters pertaining to infusion systems products. - Lead effort and study groups within regulatory department to obtain the Regulatory Affairs Certification (RAC) through Regulatory Affairs Professional Society (RAPS). - Updated internal standard operating procedures based on current global regulation.
-
-
Sr. Associate, Regulatory Affairs - Electromechanical Devices
-
Nov 2017 - Jul 2019
- Provide regulatory support and expertise associated with global and US registration of medical devices within the infusion pump and infusion software portfolios. Assure full regulatory compliance of all documentation for submissions and change management. - Plan, organize, and prepare global regulatory dossiers in line with local regulatory requirements and guidelines. - Represent global regulatory affairs within product development teams. Provide support by presenting regulatory… Show more - Provide regulatory support and expertise associated with global and US registration of medical devices within the infusion pump and infusion software portfolios. Assure full regulatory compliance of all documentation for submissions and change management. - Plan, organize, and prepare global regulatory dossiers in line with local regulatory requirements and guidelines. - Represent global regulatory affairs within product development teams. Provide support by presenting regulatory position and influence decisions concerning product development, registration, and promotion within regional markets based on this position. - Evaluate changes to existing products for regulatory impact and accurately describe these changes for regulatory agency review. - Remain informed of changes to legal and regulatory requirements within US and global markets and communicate regulatory initiatives or changes to project teams as appropriate. - Prepared gap assessment between current European regulations under Medical Device Directive (MDD) 93/43/EEC and new/upcoming European regulations under Medical Device Regulation (MDR) 2017/745. - Implemented regional standards and requirements database to identify similarities in regional registration requirements to increase efficiency and reduce submission timelines. - Implemented and managed project tracking databases for Global Regulatory Affairs to streamline communication and improve resource planning within the Regulatory Affairs department and external business partners. - Created new and updated existing standard operating procedures to maintain compliance with Health Canada regulatory requirements.
-
-
-
Medline Industries, LP
-
United States
-
Medical Equipment Manufacturing
-
700 & Above Employee
-
Associate Regulatory Manager
-
May 2017 - Nov 2017
- Oversee the management and provide regulatory support of labeling/packaging/advertising & promotion documentation to support compliance with federal and state requirements pertaining to medical devices, drugs, and cosmetics. - Provide day-to-day direction and oversight to regulatory staff. Mentor, coach, and provide guidance to regulatory team. - Facilitate relationships with internal and external business partners, specifically concerning QA/RA procedures and regulatory… Show more - Oversee the management and provide regulatory support of labeling/packaging/advertising & promotion documentation to support compliance with federal and state requirements pertaining to medical devices, drugs, and cosmetics. - Provide day-to-day direction and oversight to regulatory staff. Mentor, coach, and provide guidance to regulatory team. - Facilitate relationships with internal and external business partners, specifically concerning QA/RA procedures and regulatory requirements. - Proactively communicate relevant regulatory requirements to internal and external business partners. - Improved risk management process by re-writing standard operating procedures related to risk management per ISO 14971 and implemented Failure Mode and Effects Analysis (FMEA) process. - Helped facilitate and amend existing relationships between Regulatory Affairs and external business partners. Two staff members have won quarterly awards due to exceptional customer service and effective relationship building with external business partners.
-
-
International Regulatory Specialist
-
Jun 2015 - May 2017
- Lead International Regulatory Affairs activities and manage regulatory submissions for the European Union, Middle East, and Asia Pacific regions. - Plan, organize, and prepare Medical Device Technical Files and global registration dossiers in line with local regulatory requirements and guidelines. - Represent regulatory affairs in product development teams. Provide support by presenting regulatory position and influence decisions concerning product development, registration, and… Show more - Lead International Regulatory Affairs activities and manage regulatory submissions for the European Union, Middle East, and Asia Pacific regions. - Plan, organize, and prepare Medical Device Technical Files and global registration dossiers in line with local regulatory requirements and guidelines. - Represent regulatory affairs in product development teams. Provide support by presenting regulatory position and influence decisions concerning product development, registration, and promotion within regional markets based on this position. - Remain informed of changes to legal and regulatory requirements within the regional market and communicate regulatory initiatives or changes to other staff as appropriate. - Created submission dossier template to ensure regulatory compliance with the anticipated implementation of the Association of Southeast Asian Nations (ASEAN) Medical Device Directive. - Implemented and managed project and submission tracking databases for International Regulatory Affairs to streamline communication within the Regulatory Affairs department and the International Sales department. - Collaborated with International and US Regulatory Affairs colleagues to identify similarities in regional registration requirements to increase efficiency and reduce submission timelines.
-
-
Regulatory Specialist
-
Apr 2014 - Jun 2015
- Review product labeling, advertisement, and promotional material for various product lines for FDA compliance. - Remain informed of changes to legal and regulatory requirements pertaining to product labeling, advertising, and promotional material and communicate regulatory initiatives or changes to other staff as appropriate. - Communicate effectively with product management and quality assurance specialists to ensure processes for obtaining product material runs smoothly and the… Show more - Review product labeling, advertisement, and promotional material for various product lines for FDA compliance. - Remain informed of changes to legal and regulatory requirements pertaining to product labeling, advertising, and promotional material and communicate regulatory initiatives or changes to other staff as appropriate. - Communicate effectively with product management and quality assurance specialists to ensure processes for obtaining product material runs smoothly and the material contains correct information. - Participate in new product development teams to define regulatory requirements and influence decisions concerning labeling, advertising, and promotional material. - Maintain thorough product documentation to ensure prompt and accurate access to regulatory information. - Actively participate in process improvement projects. - Assisted in improving processes for creation of labeling and advertising/promotional material. Includes development of all-electronic labeling creation requests and improvement of organization of attachments included with the requests. - Assisted in the creation of a trademark/copyright information webpage linked on the www.medline.com website to maintain correct, consistent, and updated trademark/copyright information. - Implemented a Communication Expectation work instruction for the Regulatory Affairs – Labeling department to streamline communication between Regulatory Affairs and Product Management, Quality Assurance, and Medline international offices. - Assisted in the training of new and rotational employees including providing work instruction and opportunities for job shadowing to develop active job experience. Additionally, I made myself available as an additional resource for new and rotational employees after I moved into the International Regulatory Affairs department
-
-
-
Aramark Healthcare+
-
United States
-
Hospitals and Health Care
-
700 & Above Employee
-
Biomedical Equipment Technician
-
Jul 2013 - Apr 2014
-Perform installation, maintenance, and repair on biomedical equipment by following established guidelines. -Communicate with manufacturers to order parts and supplies necessary for servicing the equipment. -Demonstrate excellent customer service by communicating effectively within the healthcare community. -Maintain thorough and timely documentation in an organized manner. -Perform installation, maintenance, and repair on biomedical equipment by following established guidelines. -Communicate with manufacturers to order parts and supplies necessary for servicing the equipment. -Demonstrate excellent customer service by communicating effectively within the healthcare community. -Maintain thorough and timely documentation in an organized manner.
-
-
-
University of Illinois Urbana-Champaign
-
United States
-
Higher Education
-
700 & Above Employee
-
Engineering Tour Guide
-
Aug 2009 - Aug 2012
-Conduct University of Illinois Engineering Campus tours to prospective students and their families. -Answer questions about the university and its facilities.
-
-
Engineering Registration Lab Assistant
-
May 2012 - Jul 2012
-Assist incoming students attending orientation with class registration. -Answer questions about the university courses and facilities.
-
-
Women in Engineering Camp Counselor
-
Aug 2010 - Aug 2011
-Answer questions and provide guidance to incoming engineering students through teamwork and leadership activities -Help plan camp activities
-
-
Education
-
2009 - 2013
University of Illinois at Urbana-Champaign
BS, Nuclear, Plasma, Radiological Engineering -
2005 - 2009
Maine West High School
General Education; College Preparation
Community
