プロフィール詳細

プロジェクトを作成

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Juan M. C.に依頼

Spain

Medical Device quality & regulatory expert with + 33 years experience in the industry

プロフィール概要

Juan M. Campos is a Medical Device professional with + 33 years of continued industry experience. His main areas of expertise include Quality Assurance, Regulatory Compliance and Regulatory Affairs. He has led culturally and geographically diverse QA/RA teams in Spain, UK, France, Switzerland, Netherlands, Germany, Portugal, Italy, Greece and Turkey directly reporting to him. Additionally he has successfully coordinated global QA/RA projects with extended on site presence in USA and China. Most of the Regulations that govern today’s Medical Device world (EU Medical Device Directive, US FDA CFR 21-820, ISO 13485, Japan MHLW, Australia TGA, Brazil ANVISA, Health Canada, China SFDA, etc) have been created, implemented and even revised several times during Juan’s 30 year daily industry activity in leadership QA/RA roles. Specifically Juan has successfully led both product international Regulatory Registration processes, together with Regulatory Compliance global projects to ensure full Quality System compliance with those Regulations (Quality System design and implementation, Regulatory Agency pre-inspection readiness, Regulatory Agency post-inspection remediation, M&A due diligence and post-merger integration, product quality claims & liability, etc) in manufacturing, subcontractor and distribution facilities around the globe. Juan is also a certified SGS ISO 9001 Auditor, BSI ISO 13485 Lead Auditor and SGS MDR QMS Auditor & Product Assessor with extensive EMEA, China and USA on site audit experience, an active voting member of ISO TC150 CTN91 Implants and ISO TC210 CTN111 SC3 Quality Management Committees, as well as an active project evaluation expert at the BioExpert Network.

専門分野

• ★ Medical Devices
• ☆ ISO 13485
• ☆ ISO 14971
• ☆ Regulatory Affairs
• ☆ Quality Assurance & Quality Control (QA/QC)
• ☆ Product Compliance

サービス

• Writing
• Research
• Consulting
• Data & AI

Writing Clinical Trial Documentation, Technical Writing

Research Systematic Literature Review

Consulting Scientific and Technical Consulting

Data & AI Statistical Analysis

職務経験

Owner

Self-Employed

4月 2017 - 現在

EMEA Regulatory Compliance Director

Zimmer Biomet

3月 1992 - 4月 2017

Quality Assurance Manager

B Braun

8月 1990 - 3月 1992

Quality Assurance Manager

Baxter

3月 1987 - 3月 1992

学歴

Global Leadership

Notre Dame University - Indiana - USA

6月 2014 - 6月 2014

Inorganic Chemistry Degree

Valencia University

9月 1979 - 6月 1984

認定資格

• 認定資格の詳細は未入力です。