TIMOTHY J. JOINER
Global Quality & Regulatory Affairs Leader | FDA & International Compliance | QMS Expert | Device & Combination Products
Highly accomplished Quality and Regulatory Affairs leader with over 25 years of global experience in the medical device, IVD, and combination product sectors. Proven expertise in developing, implementing, and scaling compliant Quality Management Systems (QMS) aligned with FDA and international standards. Skilled in leading global submissions, regulatory strategy, inspection readiness, and post-market surveillance. Passionate about driving continuous improvement, operational excellence, and accelerating innovation to safeguard patient outcomes and enable sustainable growth.
HQ:
United States
Languages:
English
Claim status:
Claimed
Services & Capabilities
FDA 510(k) Submission Services
Jurisdictions:
US
Services Offered:
Regulatory Pathway Assessment, Device Classification Support, 510(k) Strategy & Authoring, 510(k) RTA Remediation / Refuse-to-Accept Fix, Predicate Research & Substantial Equivalence Strategy, De Novo Strategy & Authoring, PMA Strategy & Support, Pre-Sub / Q-Sub Preparation, FDA Meeting Support (Q-Sub / Type C)
Pathways Supported:
Traditional 510(k), Special 510(k), De Novo, Pre-Sub / Q-Sub
Device Types Supported:
IVD, SaMD, Medical device
Supports Rta Remediation:
Yes
Supports Predicate Research:
Yes
Years Experience:
26
Num510k Submitted:
7
Ex FDA:
No
Ex Notified Body:
No
Ex Big Medtech:
No
Device Panels:
ivd, other, cardiovascular, orthopedic, obgyn, dental, general_surgery, radiology
Technology Types:
samd, combo_product, ivd_test, mobile_app, implantable
Accepting New Clients:
No
