Company Info for mcphs.edu | IcebreakerMembers
Quality Systems Management Experience
25+ Years implementing compliant and efficient Quality Systems to ISO 9001, ISO 13485, FDA 21 CFR 820 and ISO 14971 for Pharmaceutical and Medical Device developers and manufacturers. Improve efficiency and compliance using a risk based process approach and leveraging data across the entire QMS. Specializing in FDA 483 and warning letter remediation, multisite QS integration, and ISO implementation, revisions, and certifications.
Regulatory Affairs Management Experience
15+ years regulatory compliance including 21CFR 801, 803, 806, 807, EU MDD/MDR 2017-745, JPAL, CMDR US agent for foreign manufacturers
Skills and Experience
Thorough understanding in the application and integration of QMS 21CFR 820, ISO 13485-2012 & 2016, Device tracking 21CFR 821, Unique Device Identification (UDI) 21CFR 830, MDSAP and engineering standards (ASTM AAMI, IEC, EN ISO).
Experienced in performing acquisition due diligence, multi-site QMS integration, Supplier/Internal/GAP audits, cost reduction and process improvement (compliance and lean/efficiency) projects.
Strong computer skills including the implementation of automated QMS, PLM, MRP/ERP solutions. Master Control, Pilgrim SmartSolve, Salesforce, Planview, etc.
Knowledgeable in domestic and international regulatory requirements for Pharmaceuticals & Medical Devices, combination Device/Pharma, Human Tissue, EU MDD/MDR , SOR/CMDR, 21CFR part 11, 801, 803, 806, 807, 812, 814, 210, 211, 1270, 1271), MDSAP, and American Association of Tissue Banks (AATB).
Proactive integration of revisions to engineering standards (i.e. IEC 60601, 62304, 62366) during all phases of design controls to ensure smooth 510ks and other regulatory submission processes.
Experience as lead negotiator with FDA, ISO and other regulatory agencies during facility inspections, recalls, MDRs. 
RESEARCH ADMINISTRATION:
MS Mgmt-Research Administration (2012), studied Business Research, Organizational Behavior, Organizational Development, Compliance, Government Regulation, HSR (human subjects research), RCR, Research Ethics & History, Finance, Strategic Planning and Management.
YEARS OF TUTORING:
Human Anatomy & Physiology I & II, Personal Psychology, Office Policy, Computer Billing, Medical Office Skills, Clinical Procedures I & II, Healthcare Career Development, English, ESL, ESOL, Grammar, Business English, Medical Terminology I & II, Medical Law and Ethics, College-Level Philosophy, Computer Hardware, Computer Networking, Computer Repair
CAREER INTERESTS:
Research Administration, Public Health, Community Health, Energy Policy, Climate Ethics, Bioethics, Clinical Ethics, Social Science, Counseling, History
MARKETING and COMMUNICATIONS (Marcom): Problem resolution, client prospecting, networking, customer service, presenting, public speaking, training and development, networking, promotion, personal development, tutoring, qualifying, branding, counseling, social capitalism, green, comparative religion, social science, online media, credentialed experienced Wikipedian
BUILDING VEGETARIAN COMMUNITY: Started Boston Vegetarian Society, Vegetarian Resource Center, Boston Vegetarian Food Festival: Vegetarianism, veganism, vegan food, meditation, nutrition, group and career development, advising new businesses; spoke at vegetarian conferences, meetings, events on related topics
* Innovative Driving Force in veg*n community development
* Transformational Leader translating opportunity gaps into concepts, inspiring creativity and enthusiasm from global teams to deliver market-leading services and processes.
*Thought Leader Communicates Vibrant Messages
Twitter: @HarvardVegan
Facebook: Maynard.Clark
Blog links: http://Maynard.Clark.GooglePages.com
Editing, Report Writing, Social+Religious History, Vegetarianism, Veganism, Animal Ethics, Plant-Based Nutrition, Board Service 
I am a Sr. Digital Marketing Manager at Massachusetts College of Pharmacy and Health Sciences (MCPHS).
Established in 1823, MCPHS is a private, not-for-profit university that offers more than 100 programs in the health and life sciences across three campuses in Massachusetts and New Hampshire and online. For generations, MCPHS graduates have gone on to play vital roles in pharmacies, emergency rooms, academic labs, government agencies, boardrooms, and beyond. The University is consistently ranked one of the most transformative universities in the United States, effectively preparing students for the workforce. It monitors developments in the healthcare marketplace and evolves its programming to meet emerging needs. These efforts are rooted in service to humanity. MCPHS is committed to building a healthier, more equitable world. 
