Role listed
Self-Employed
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Tim M. Lohnes Email & Phone Number
Independent Medical Device Regulatory and Quality Systems Consultant
at
Self-employed
1 work email found
@lumendi.com
LinkedIn matched
✓ Verified Jul 2026
4 data sources
Profile completeness 100%
Current company
Self-employed
Role
Independent Medical Device Regulatory and Quality Systems Consultant
Location
New York City Metropolitan Area, United States
Who is Tim M. Lohnes? Overview
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Quick answer
Tim M. Lohnes is listed as Independent Medical Device Regulatory and Quality Systems Consultant at Self-employed, based in New York City Metropolitan Area, United States. AeroLeads shows a work email signal at lumendi.com and a matched LinkedIn profile for Tim M. Lohnes.
Tim M. Lohnes previously worked as Independent Regulatory and Quality Systems Consultant at Self-Employed and Independent Regulatory Consultant at Self-Employed. Tim M. Lohnes holds Associate’S Degree, Business Administration And Management, General from Ct State Norwalk.
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tlohnes@lumendi.com
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Profile bio
About Tim M. Lohnes
Tim M. Lohnes is an experienced Medical Device regulatory professional who made significant contributions to the development of the US Surgical (now Medtronic) laparoscopic device line, as well as their suture, mesh, and orthopedic product lines. His experience in the development of advanced surgical device design and application is complimented by his extensive background in Quality Systems Management, Design Control, and Regulatory Affairs. He has a proven track record in obtaining FDA and CE Mark clearance, as well as developing and maintaining strategies and procedures to ensure and maintain compliance with regulatory requirements . He has extensive supervisory experience in educating, motivating, and developing staff and recognizing talented individuals. During his tenure as Manager of Regulatory Affairs and Quality Assurance at Precision X Ray, Tim guided and advised on RA/QA issues during a major merger and integration effort, providing effective solutions to maintain compliance, determine best practices, and establish standards for procedures.Tim's previous position with Life Global (now Cooper Life Sciences) introduced him to the regulatory issues involved with In Vitro Fertilization media, particularly dealing with LG's Notified Body. Tim also prepared Life Global for their MDSAP qualification audit. During his tenure as a consultant with Orchid Orthopedic Solutions, Tim gained critical, in depth experience with the new 510(k) paradigm, developing and overseeing successful submission strategies that anticipated and exceed the expectations of FDA reviewers. Specialties: Medical device 510(k) and PMA submissions; US, Canada, Japan, EU and R.O.W. product registrations; regulatory strategy & project management, Unique Device Identification, Quality Systems compliance, development and management including 21 CFR 820 & ISO 13485, device and drug labeling/advertising & promotion compliance; staff supervision and development
Listed skills include Fda, Medical Devices, Iso 13485, Design Control, and 42 others.
Current workplace
Tim M. Lohnes's current company
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Self-Employed
10 roles · 41 years
Tim M. Lohnes work experience
A career timeline built from the work history available for this profile.
Independent Regulatory And Quality Systems Consultant
Current
Self-Employed
Jan 2021 - Present
Independent Regulatory Consultant
Current
Self-Employed
Jan 2021 - Present
Independent Regulatory Consultant
Independent Regulatory Consultant
Provides strategic guidance and execute specific independent & team based functions for clients, including regulatory submissions & registrations, quality system improvements & development, design control, risk management, and standards compliance.
Sep 2015 - Jan 2021
Manager
Manager, Regulatory & Quality Assurance, Precision X Ray
Nov 2018 - Sep 2019
Director, Regulatory Affairs
Life Global Group,
Directed the review and approval of 3 MDD Class III Design Dossiers for various In Vitro Fertilization media; established ISO 13485:2016 and EN 14971:2012 compliant documentation & procedures for IVF media & equipment; led response to Notified Body certification and FDA surveillance audits; developed & initiated strategies for Medical Device Single Audit Program (MDSAP) and Medical Device Regulation compliance.
Mar 2017 - Nov 2018
Senior Regulatory Consultant
Provided primary support for domestic (US) and international Regulatory issues to a number of small to mid-size medical device clients, primarily Quality Systems development, compliance analysis and application strategy and device submissions. Provided support to clients for regulatory issues including establishment and product registration, certificate/registration renewals (Canada, Australia, Brazil, etc.), served as US Agent to non-US based clients, provided support during FDA and Notified Body audits, as well as recall and warning letter response strategy. Provided Regulatory support and strategy for the development and deployment of Unique Device Identification systems for three mid-sized device manufacturers. Developed strategy, authored, submitted, and administrated review process for four cleared (client owned) 510(k) submissions and three Class III Annual Reports, as well as two EU Class III Design Dossiers and three Class III re-certifications. Served as primary contact to FDA and Notified Body reviewers to provide regulatory technical support and liaison with client engineering and/or management. Provided functional Regulatory support to Orchid Design and its affiliates, including process development, audit support, Quality Systems compliance analysis and support.
Oct 2012 - Nov 2015
Regulatory Affairs Manager
Lead and manage a broad spectrum of activities under minimal direction, including developing regulatory strategies for FDA and international submissions during new product development and regulatory maintenance of legacy/mature products. Developed, submitted, and administered 7 (seven) 510(k) and 5 (five) Design Dossiers to FDA/Notified Bodies over 4 years, including new and acquired products. Facilitated global registration activities with international partners, overseeing implementation of in-country market approvals.
Jul 1986 - Sep 2012
Quality Assurance Manager
1986 - Jan 2002
Supervisor
Us Surgical (Covidien)
1986 - 1998
~12 yrs
1 education record
Tim M. Lohnes education
-
Ct State Norwalk
FAQ
Frequently asked questions about Tim M. Lohnes
Quick answers generated from the profile data available on this page.
What company does Tim M. Lohnes work for?
Tim M. Lohnes works for Self-employed.
What is Tim M. Lohnes's role at Self-employed?
Tim M. Lohnes is listed as Independent Medical Device Regulatory and Quality Systems Consultant at Self-employed.
What is Tim M. Lohnes's email address?
AeroLeads has found 1 work email signal at @lumendi.com for Tim M. Lohnes at Self-employed.
Where is Tim M. Lohnes based?
Tim M. Lohnes is based in New York City Metropolitan Area, United States while working with Self-employed.
What companies has Tim M. Lohnes worked for?
Tim M. Lohnes has worked for Self-Employed, Independent Regulatory Consultant, Manager, Regulatory & Quality Assurance, Precision X Ray, Life Global Group,, and Orchid Orthopedic Solutions.
How can I contact Tim M. Lohnes?
You can use AeroLeads to view verified contact signals for Tim M. Lohnes at Self-employed, including work email, phone, and LinkedIn data when available.
What schools did Tim M. Lohnes attend?
Tim M. Lohnes holds Associate’S Degree, Business Administration And Management, General from Ct State Norwalk.
What skills is Tim M. Lohnes known for?
Tim M. Lohnes is listed with skills including Fda, Medical Devices, Iso 13485, Design Control, Quality System, Regulatory Affairs, Clinical Trials, and Capa.
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