Medical device/Pharma/Vaccines/Cosmetics, EU MDR 2017/745&2017/746, MQSR/21CFR,ISO certification, ISO 13485:2016, MDSAP...

Medical device, Pharma, Vaccines, Cosmetics, Nutraceuticals, combination products: QA, RA, compliance/ regulatoy intelligence, project management, risk management, remediation, biocomptibility, mgt of poeple, design controls, trainer, keynoter,

• Business Development
• Innovationsmanagement
• Projektmanagement - Lehrgänge8 J.
• Qualitätssicherungssysteme8 J.

Highly accomplished Healthcare Executive with over 20 years of experience spanning the pharmaceutical, medical device, and vaccine industries. Expertise across therapeutic areas such as oncology, inflammatory diseases, neurodegenerative conditions, cardiovascular diseases, trauma, and orthopedics. A strong background in pharmacovigilance (QPPV), regulatory compliance, quality assurance, clinical trials, and drug development, complemented by over 10 years in academic research and lecturing at international conferences. Proven success in project management, business leadership, and building cross-functional teams in diverse geographical regions including Europe, MENA, Africa, Asia, and LATAM.

KEY ACHIEVEMENTS
Scientific Development: Conducted groundbreaking research in organic therapeutic chemistry and electrochemical methods, including the development of monobactam compounds with anti-HIV properties. Published six scientific papers and contributed to numerous congresses.
Business Leadership: Created three pharmacovigilance departments and developed a center for PV training, driving operational efficiency and compliance across multiple companies. Led the commercialization of university research, fostering the growth of new ventures.
Strategic Partnerships: Negotiated contracts and established collaborations between CROs, pharmaceutical companies, and distributors. Developed and managed outsourcing projects for CROs, including budget control and business expansion initiatives.
Regulatory & Quality Success: Led regulatory remediation projects for medical devices and pharmaceuticals, ensuring compliance with ISO and FDA regulations. Developed and implemented CAPA systems, audit readiness, and change control processes

Scientific Expertise: PhD in Electrochemistry, advanced research in organic chemistry, therapeutic compounds, and nanotechnology applications.
Business Development: Extensive experience in negotiating contracts, budget management, and building strategic partnerships across CROs, pharmaceutical companies, and distributors.
Project Leadership: Led large-scale projects in Quality Assurance (QA), Regulatory Affairs (RA), and Pharmacovigilance (PV), from concept to market.
Regulatory & Compliance Leadership: Expertise in MDR, MDSAP, ISO 13485, GCP, GVP, FDA QMSR, EU MDCG, ICH, US FDA, Swissmedic, EMEA, MHRA, WHO, ANVISA, ISO, PIC/S, ISO 9001:2015; Meddev, CIOMS; Eudralex; PIC/S, 21CFR11, 21CFR820, 21CFR210 & 211 (cGMP), EudraCT; ISO 10993-1 to 18 and FDA biocompatibility guidance, 21 CFR part 11, 210 and 211, Annex 11, EU-GMP guidelines and GAMP and global standards for regulatory and quality compliance.

Scientific Research & Development:
Led research in therapeutic chemistry, specializing in electrochemistry methods, nanotechnology, and organic compound synthesis. Collaborated with international labs on fine chemicals research.
Delivered over 10 years of university-level teaching in general and organic chemistry, supervising research projects and contributing to academic publications.
Business Development & Consultancy:
Developed and executed business strategies, including contract negotiations, project management, and commercialization of pharmaceutical and medical device products.
Created pharmacovigilance departments and managed outsourcing projects, enhancing operational capacity and compliance for CROs and pharmaceutical companies.
Brokered contracts for pharmaceutical goods, medical devices, and food supplements, establishing a network of international distributors and driving business growth.
Regulatory & Quality Assurance Leadership:
Directed QA & RA teams in compliance projects (ISO, MDSAP, MDR, FDA), leading successful audits and regulatory submissions.
Managed complex projects in medical devices and drug development, including drafting protocols, aggregate reports, and risk management documentation.