Bob Laughner
Senior Regulatory & Quality Executive | FDA, ISO 13485, eCTD, QMS, Design Controls │ MedTech ▪️ Pharma ▪️ Combination Products ▪️ Global Submissions & Compliance Strategy
- Role
- Senior Vice President - Regulatory & Quality at Orchestra BioMed
- Location
- Fort Lauderdale, FL, US
- LinkedIn followers
- 500 followers
About Bob Laughner
Regulatory and quality executive helping patients by delivering safe and effective medical innovations.Demonstrated success in building effective partnerships across multiple business functions and geographies to deliver results. Experience in interfacing with regulatory agencies and negotiating with regulators. Expertise in development, testing, and regulation of drugs, medical devices, and combination products. Experience in developing regulatory strategies for domestic and international markets.Specialties: Regulation, Development, and Testing of Drugs, Medical Devices, and Combination ProductsBiocompatibility of medical devices and combination productsClinical evaluation and critical analysis of scientific/medical literature.
Experience
Senior Vice President - Regulatory & Quality
Nov 2023 — Present · Fort Lauderdale, FL, US
Education
Indiana University Bloomington
BA, Biology
2000 — 2003
Karolinska Institutet
Certificate, Introduction to Pharmaceutical Medicine
2017 — 2017
Indiana University Bloomington
MS, Pharmacology
2003 — 2007
Skills
- Toxicology
- Laboratory
- Fda
- Regulatory Strategy Development
- Regulatory Intelligence
- Cross-Functional Team Leadership
- Biomaterials
- Regulatory Submissions
- Combination Products
- Regulatory Science
- Pharmacology
- Biocompatibility
- Medical Devices
- Pharmaceutical Sciences
- Chemistry
- Iso 13485
- Biotechnology
- Regulatory Affairs
- Gmp
- Drug Eluting Stents
- Product Development
- Clinical Evaluation
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