About
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The strength of Chas Burr Q/R Services is my extensive experience and ongoing involvement in quality and regulatory affairs.
A career in medical technology
My entire career has been in medical technology, both in a teaching hospital of the Harvard Medical School and in the medical device industry. Since 1986, my career has focused on regulatory and quality leadership. Responsibilities at Hewlett-Packard (HP) Medical Products included numerous regulatory and quality management positions supporting large and small operations. (HP Medical Products was spun off as Agilent Technologies Healthcare Solutions Group in 1999, and is now part of Philips Medical Systems.) Developing and teaching graduate courses in regulatory affairs at Northeastern University is my part-time "labor of love."
Experienced with large businesses
At HP my responsibilities included group-wide and multi-division management. I established regulatory and quality system strategy, policy, and support services.
In ten years as Regulatory Manager for the Imaging System division, I authored product approval submissions, was active in trade association and standards development activities, and supervised regulated aspects of the quality system, including internal and external audits, complaint and safety investigations, and recalls.
Experienced with small businesses
I supported small and re-organized HP operations including an internal start-up, a manufacturing operation in China, the Andover manufacturing operation that supported most Medical Products Group divisions, and the Clinical Cardiology operation.
Most recently at a start-up, Argose, Inc., I developed quality system and regulatory strategies, established business infrastructure and processes, and coordinated development of clinical affairs and quality assurance.
Experienced with consulting
Since the start of Chas Burr Q/R Services in 2002, I have worked with medical device companies large and small.
I look forward to putting my experience to work for your company's success.
Read more about my past projects and experience.
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