Independent Quality Systems Associates, Inc.

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Rollin Heinzerling, Ph.D.

CAREER SUMMARY

Highly successful "hands on" director of regulatory affairs and quality assurance with years of experience in product development and manufacturing. Competent and knowledgeable in FDA regulations, FDA 510(k) and PMA filings, foreign registrations, and Quality Systems requirements and documentation.

Strengths include strategic planning, excellent background in patents and intellectual properties, regulatory issues, and team building.

EXPERIENCE HIGHLIGHTS

Regulatory - Designed, implemented, filed and received approval on numerous 510(k)s on reagent kits. Directed, designed and partially wrote 2 cervical cytology PMAs (monolayer preparations (received approval) and digital automated computerized screening (submitted)). This included clinical protocol development and non-clinical trials designing and management. Designed, developed, and reviewed hardware and software validation for cervical preparations, digital imaging, and Intraocular lens manufacturing. Set up, managed and audited both clinical trials. Was the lead person through one FDA sponsor and 2 GMP audits. Gave scientific presentations and data analysis at numerous FDA meetings.

Quality - Directed and implemented a complete quality system at AutoCyte. Worked with the quality assurance group to develop necessary skills for their positions. Developed a GMP system for production of reagents and instrumentation with a successful inspection. Changed the corporate philosophy from adversarial to partnership with the FDA. Worked with our quality group to initiate design control, purchasing control and initial ISO 9001 certification.

R&D and Production - Managed a total immunoassay system program, including FDA filings and transfer of over 15 assays into production. Worked with marketing and production to promote and maintain all the assays and programs. Established three different development teams. Started an additional support group in molecular modeling.

Expertise as a manager and director.

• Performed strategic planning and worked on the long-range plans.
• Creating complete Quality System companies that will pass inspection.
• Recruited consultants and developed contractual agreements.
• Recruited clinical sites and conducted clinical testing.
• Developed protocols, setup clinical sites, compiled data and wrote PMAs and 510(k)s.
• Managed quality and developmental groups with positive reinforcements.
• Promoted teams interaction in work and development of ideas.
• Worked with personnel as a "hands on" manager.
• Helped market products nationally and internationally.
• Trouble-shot production problems.

WORK HISTORY

Medical Developmental Research - Regulatory and QA manager
Clearwater, FL 3/2000-10/2000 - have reduced work to consulting role

• Reconstructed a quality system the pasted FDA and ISO.
• Performed numerous process and software validations.
• Retrained personnel in quality processes.

QaRAC Quality and Regulatory Affairs Consulting. 6/1999 to present Principle Director
Responsible for correcting Quality Systems, writing non-clinical studies, Clinical Protocol Development, PMA Clinical submission, IDE development and submission, and Clinical trials data base for various clients.

AutoCyte, Inc., formerly Roche Image Analysis Systems Inc. 6/1993 - 6/1999
Director Regulatory Affairs and Quality - Elon College, NC

• Directed, designed and partially wrote 2 cervical cytology PMAs.
• Wrote clinical protocol, clinical and non-clinical trials.
• Set up, managed and audited both clinical trials.
• Gave numerous scientific presentations at FDA meetings.
• Directed and implemented a complete quality system.
• Initiate design control, and initial ISO 9001 certification.

INCSTAR Corporation - Stillwater, MN
8/1986 - 4/1993 Director R&D

• Managed a total immunoassay system program.
• Developed FDA filings and transferred 15 assays into production.
• Worked with marketing and production to promote and maintain all the assays and programs

Kallestad Laboratories - Chaska, MN
8/1985 - 8/1986 Manager of Immunology Product Development

• Managed a total immunoassay system program.
• Wrote 510(k)s and transferred products into production

Abbott Laboratories - North Chicago, IL
7/1983 - 8/1985 Group Leader Product Development

• Lead auto-immune assay development program.
• Leader of False Positive control team for first HIV assay

Henry Ford Hospital - Detroit, MI
6/1974 - 8/1983 Staff Member, Clinical Immunology

• Developed immunoassay and ran the auto-immune program.
• Worked with Dermatology, Allergy, and Cardiology on research and helped write numerous papers.

U.S. Army Medical Research and Nutrition Labs - Denver, CO
2/1969 - 3/1971 Research Specialist

• Worked on various medical programs for the Vietnam War.

EDUCATION

• Ph.D. Degree Colorado State University, Fort Collins, CO 1974 Major: Microbiology Specialization: Immunology, Biochemistry
• M.A. Degree University of Northern Iowa, Cedar Falls, IA 1969 Major: Biology Specialization: Molecular Biology
• B.A. Degree University of Northern Iowa, Cedar Falls, IA 1969 Major: Chemistry
• Attended and participated in numerous workshops and conferences on FDA regulation including the Device Summit Meeting in 1995 at Park City UT

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