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Science & Biotech Online Resumes

Clinical Regulatory Affairs

Clinical Regulatory Affairs

Clinical Regulatory Affairs

Clinical Regulatory Affairs

Clinical Regulatory Affairs

Clinical Regulatory Affairs

Clinical Regulatory Affairs

Production Technician

Regulatory Affairs, Quality, and Clinical Evaluation Consultant to Medical Device Industry

PROFESSIONAL PROFILE: A focused, driven, and passionate regulatory affairs and quality/compliance/auditing consultant with hands-on experience in RA and Quality/Compliance/Auditing associated with activities which lead to, and maintain regulatory approval to ISO 13485, FDA 510 (k), EU CE Mark & other international market authorizations of medical device products and conformance/compliance of Quality Management Systems. Regu...

Tags for this Online Resume: Management, Regulatory Affairs, Assessments, Audit, Budgeting, ISO, Microsoft Office, Quality, Quality Assurance, Quality Management, oncology, protocol, 13485, FDA, 483, Warning Letter, Portuguese, Spanish, ANVISA, Lead Auditor, Quality Systems, Quality Audit, Medical Device

Regulatory Affairs Specialist - 16 Years of Experience - Near 19464

An accomplished records and information management specialist with proven skill set including 16 years’ experience within records retention and information management. Focus on health authority audit preparedness, compliance, security, and lifecycle management requirements of key company proprietary media encompassing all GXP documentation. Actively liaise with internal areas and external groups including CMOs and CROs to ...

Tags for this Online Resume: Filing, Management, Quality, Quality Assurance, Quality Control, Retention, Document Management, Documentation, Information Technology, Records and Information Management, Regulatory, Operations, Record Coordinator, Compliance, Regulatory Operations

Clinical Regulatory Affairs

Clinical Regulatory Affairs

PROFILE Quality Assurance and Regulatory Affairs professional with experience in the medical device manufacturing industry. Developing and introducing FDA Class I & II digital medical x-ray equipment, laser radiography scanners, pharmaceutical ultra and micro filtration and separation filters, and blood filters. Manage and develop Quality functions (quality planning, new product development, design controls, quality enginee...

Tags for this Online Resume: Email, Engineering, Medical, Medical Devices, Pharmaceutical, Problem Solving, Quality, Quality Assurance, Statistical Analysis, Test