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Contact Juan M. C.

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Profile Details

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USD 150 /hr

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Hire Juan M. C.

Spain

USD 150 /hr

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

Profile Summary

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.

Subject Matter Expertise

Services

Writing
Research
Consulting
Data & AI

Writing Clinical Trial Documentation, Technical Writing

Research Systematic Literature Review

Consulting Scientific and Technical Consulting

Data & AI Statistical Analysis

Work Experience

Owner

Self-Employed

April 2017 - Present

EMEA Regulatory Compliance Director

Zimmer Biomet

March 1992 - April 2017

Quality Assurance Manager

B Braun

August 1990 - March 1992

Quality Assurance Manager

Baxter

March 1987 - March 1992

Education

Global Leadership

Notre Dame University - Indiana - USA

June 2014 - June 2014

Inorganic Chemistry Degree

Valencia University

September 1979 - June 1984

Certifications

Certification details not provided.