Rob Mclain Email & Phone Number
@uromedica-inc.com
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Who is Rob Mclain? Overview
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Rob Mclain is listed as Contract Technical File Reviewer at DEKRA North America, based in Greater Minneapolis-St. Paul Area, United States. AeroLeads shows a work email signal at uromedica-inc.com and a matched LinkedIn profile for Rob Mclain.
Rob Mclain previously worked as Sr. Quality and Regulatory Affairs Consultant at Keystone Regulatory Services, Llc and Quality and Regulatory Engineer, Management Rep at Uromedica, Inc.. Rob Mclain holds Bsme, Mechanical Engineering from Grove City College.
Email format at DEKRA North America
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AeroLeads found 1 current-domain work email signal for Rob Mclain. Compare company email patterns before reaching out.
About Rob Mclain
Rob Mclain is a Contract Technical File Reviewer at DEKRA North America. He possess expertise in quality system, iso 13485, quality assurance, quality management, quality auditing. Colleagues describe him as "I had the privilege of working closely with Rob for over 6 years at a medical device startup. Rob served as our QMS Management Rep., our primary point of contact with external regulatory bodies, and as a sharp do-it-all engineer for countless quality, regulatory, and technical product/process development projects. He helped bring us out of the stone age of paper by implementing and maintaining our eQMS. He was our EU MDR implementation mastermind and project leader. And much more. Through it all, Rob demonstrated high ownership of everything that was assigned to him. He worked with remarkable aptitude and efficiency to get the job done, whatever it was, and it was always done well. He made my job as his manager easy; he is independent, self-motivated, and highly reliable. As a team member, he always did more than his fair share. I especially appreciated Rob's ability to write clearly, an essential trait in this industry. Rob was also really fun to work with - he has a great sense of humor and a steady, calm, and friendly disposition."
Listed skills include Quality System, Iso 13485, Quality Assurance, Quality Management, and 1 others.
Rob Mclain's current company
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Rob Mclain work experience
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Sr. Quality And Regulatory Affairs Consultant
Quality And Regulatory Engineer, Management Rep
- Lead regulatory implementation projects for new regulations, standards, and initiatives (EU MDR 2017/745, MDSAP, ISO 13485:2016, etc.)- Quality Systems: lead management review meetings, serve as the primary point of contact for internal and external audits, perform final review prior to product release, manage document control system, manage complaint handling and regulatory reporting activities, manage corrective and preventative actions, manage QMS training activities and records, perform supplier qualification activities including supplier audits, and disposition non-conforming material.- Quality system compliance with applicable requirements/standards (ISO: 13485, 21 CFR 820, etc.)- Maintain certifications, registrations, and licenses (e.g. FDA, Notified Body, Health Canada, Australia TGA, etc.)- Serve as the local administrator of QA software platform.
Engineering Intern
Engineering Intern
Rob Mclain education
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Grove City College
Frequently asked questions about Rob Mclain
Quick answers generated from the profile data available on this page.
What company does Rob Mclain work for?
Rob Mclain works for DEKRA North America.
What is Rob Mclain's role at DEKRA North America?
Rob Mclain is listed as Contract Technical File Reviewer at DEKRA North America.
What is Rob Mclain's email address?
AeroLeads has found 1 work email signal at @uromedica-inc.com for Rob Mclain at DEKRA North America.
Where is Rob Mclain based?
Rob Mclain is based in Greater Minneapolis-St. Paul Area, United States while working with DEKRA North America.
What companies has Rob Mclain worked for?
Rob Mclain has worked for Dekra North America, Keystone Regulatory Services, Llc, Uromedica, Inc., and Essential Medical, Inc..
How can I contact Rob Mclain?
You can use AeroLeads to view verified contact signals for Rob Mclain at DEKRA North America, including work email, phone, and LinkedIn data when available.
What schools did Rob Mclain attend?
Rob Mclain holds Bsme, Mechanical Engineering from Grove City College.
What skills is Rob Mclain known for?
Rob Mclain is listed with skills including Quality System, Iso 13485, Quality Assurance, Quality Management, and Quality Auditing.
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