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Dynamic Regulatory Affairs Analyst with extensive experience at Dr. Reddy’s Laboratories, adept at preparing and submitting DMFs in CTD format. Proven ability to respond to regulatory queries and ensure compliance with ICH and USFDA guidelines. Strong analytical and communication skills drive successful cross-functional collaboration and regulatory strategy execution.
Seasoned Regulatory Affairs Analyst with comprehensive background in pharmaceutical and medical device industries. Strong ability to interpret regulations, develop strategies for product submissions, and manage regulatory activities. Notable strengths include strong analytical skills, adaptability, and communication proficiency. Successfully ensured compliance in previous roles and contributed significantly to the achievement of company objectives.

Regulatory Analyst Highly experienced Regulatory Affairs Technical Writer with over 5 years of expertise in the medical domain. Demonstrated technical proficiency in IVD and medical device regulations, with a proven track record of delivering high-quality, detailed-oriented work. Adept at working independently and collaboratively within regulatory affairs teams to achieve organizational goals. Seeking a new opportunity in a culture that values growth, quality, job satisfaction, self-development, and success.

Detailed-oriented and result-driven Regulatory Affairs Specialist with over 5 years of experience in the medical device industry specializing in regulatory submissions and auditing quality management system(QMS) in compliance with ISO 13485, FDA 21 CFR Part 820, EU Medical Device Regulation (MDR), and ISO 14971, ensuring organizations meet regulatory requirements and maintain high-quality standard An in depth knowledge in risk assessment, root cause analysis, and developing corrective and preventive actions (CAPA). Strong analytical skills, attention to detail, and a commitment to continuous improvement.
Skilled at preparing and submitting regulatory documentation, including reviewing materials, technical data and accuracy of filings. Articulate and personable with exceptional data analysis, report writing and recordkeeping abilities.
Possesses versatile skills in project management, problem-solving, and collaboration. Brings fresh perspective and strong commitment to quality and success. Recognized for adaptability and proactive approach in delivering effective solutions.

Highly accomplished Regulatory Affairs & Quality professional with over 20 years of international experience spanning medical devices, chemical compliance, food and feed additives, clinical research, and laboratory management. Proven track record as Person Responsible for Regulatory Compliance (PRRC) under EU MDR/IVDR, with hands-on expertise in CE Marking, FDA submissions, ISO 13485 QMS implementation, and post-market surveillance. Combines deep scientific knowledge (Molecular Biology & Biotechnology) with multilingual communication skills (6 languages) and a reputation for building regulatory strategy from the ground up.
Quality management professional with robust experience in driving process improvements and ensuring compliance with industry standards. Skilled in root cause analysis, auditing, and quality control methodologies. Strong focus on team collaboration and achieving results, adaptable to changing needs. Known for reliability, problem-solving abilities, and effective communication.
Quality management professional with history of driving process improvements and ensuring compliance with stringent quality standards. Proven ability to collaborate effectively with cross-functional teams and achieve significant results. Known for reliability and adaptability in dynamic environments, with strong skills in process optimization and quality assurance.

Arthur Churchwell

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Client Regulatory Analyst

Paralegal

Advisory Coordinator

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Master of Arts - Threat Intelligence (Specialization in Financial Crime)

Bachelor of Arts - Economics

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Client Regulatory Analyst

Paralegal

Advisory Coordinator

Master of Arts - Threat Intelligence (Specialization in Financial Crime)

Bachelor of Arts - Economics

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