Jack Cummings

Jack Cummings has over 7 years of experience in the quality assurance and regulatory affairs field, with a focus on medical device reporting. Jack is currently the Director of Quality & Regulatory Affairs at Mammotome, a leading provider of breast biopsy solutions. Prior to their current role, Jack was the Regulatory Quality Engineer at Haag-Streit USA from August 2018 to December 2019. In this role, they were responsible for submissions of all MDR, Vigilance, and other regulatory reports to the appropriate regulatory authorities globally. Jack also managed and maintained an efficient Medical Device Reporting workflow and work assignments to achieve complete, accurate and timely medical device reporting.

Before their time at Haag-Streit USA, Jack was the Regulatory Compliance Coordinator at Cincinnati Sub-Zero from September 2016 to August 2018. In this role, they were responsible for investigating and evaluating potential reportable event complaints to determine medical device reporting requirements as defined in US FDA Regulations FDA 21CFR, European Medical Device Directives MDD 93/42/EEC, Canadian Medical Device Regulations SOR/98-282 and other International Regulations. Jack also interfaced with Regulatory Authorities (FDA/Health Canada/MHRA) as a subject matter expert during audits, responding to inquiries, and providing investigation details as required.

From June 2013 to September 2016, Jack was the Quality Assurance & Regulatory Affairs - MDR Analyst at Hill-Rom. In this role, they drafted and reviewed regulatory responses related to Post Market Surveillance, maintained metrics for the Adverse Event reporting process, provided support to the eMDR process and software working with IT, and supported the PMS complaint analysts related to product knowledge and reportability. Jack also attended the Indiana Medical Device Manufactures Council 2014 Regulatory 101 Course.

Hill-Rom is a leading worldwide manufacturer and provider of medical technologies and related services for the health care industry, including patient support systems, safe mobility and handling solutions, non-invasive therapeutic products for a variety of acute and chronic medical conditions, medical equipment rentals, surgical products and information technology solutions. Hill-Rom's comprehensive product and service offerings are used by health care providers across the health care continuum and around the world in hospitals, extended care facilities and home care settings to enhance the safety and quality of patient care.

Jack Cummings has a Bachelor’s Degree from the University of South Carolina with a 3.4 GPA. Jack also has a C License from the United States Soccer Federation in the 7v7 Soccer model. Lastly, they attended The Summit Country Day School.

They work with Jonson Qian - General Manager, China, Uwe Soeder - CFO, and Elizabeth Cotton - Senior Director, Human Resources. Their manager is Mike Feld, President.