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Online Resumes with "International Submissions"
Goal focused Quality Leader in medical devices and pharmaceuticals
Began career with 10 years with the FDA in the Detroit District office and at the Kalamazoo, MI and Grand Rapids Resident Posts. Conducted inspections at pharmaceutical and medical device companies, conducted investigations and testified in court. I Left for a start-up medical device contract manufacturer where I developed the quality system and initiated 510(k) submissions. I also identified and resolved problems result...
Ideal Companies: Small to large medical device or pharmaceutical companies such as Abbott Laboratories, Baxter, CR Bard, Phillips, Medtronic, Boston Scientific, St. Jude Medical, Johnson & Johnson, Bausch and Lomb.
Tags for this Online Resume: Quality Systems Management, Regulatory Compliance, ISO 9001:2000/ISO 13485:2003, Pharmaceutical GMPs
Worldwide Director of Regulatory Affairs
Strategic Regulatory Affairs Professional with diverse and progressive experience leading growing or established companies in the pharmaceutical, biotech and medical device industry providing global strategic regulatory direction for both new and existing products, as a primary contact facilitating preparation of international regulatory documents. Advances the development of knowledge, products, people, collaboration, c...
Tags for this Online Resume: Product Registration, CMC, International Submissions, Global regulatory, BLA, INDs, Orphan Drugs, Project Management, Bilingual, International regulations
Art Director - 20 Years of Experience - Near 01930
Techinal Expertise * Evolved the World Congress feel, modernizing brochures and signage with updated Adobe Photoshop graphics, colors, messaging, and typography. InDesign * Managed large corporate re-branding including internal submissions and external agency RFPs. Illustrator Acrobat Pro * Collaborated with senior executives and web developers to re-brand main and microsites Lightroom with new wireframes and content. Dream...
Ideal Companies: Chewy, Life is Good
Tags for this Online Resume: Advertising, Ecommerce, Email, Layout, PET, Retail, Web, Adobe, Adobe Acrobat, Adobe Illustrator
