Independent Quality Systems Associates, Inc.

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Annette Hillring, RAC

PROFESSIONAL EXPERIENCE

Hillring & Associates, Inc. 11/98 - Present

• President

Regulatory Affairs consulting for the medical device industry.

Critikon, division of Ethicon, Inc., a Johnson & Johnson Company 8/87 - 11/98

• Class II electronic cardiovascular and respiratory devices
• Class II sterile disposable general hospital devices
• Director, Regulatory Affairs 1995-1998
• Senior Regulatory Affairs Associate 1991-1995
• Regulatory Affairs Associate 1987-1991

Company FDA liaison. Represent Regulatory Affairs on new product development and corrective action teams. Prepare FDA premarket notifications [510(k)s]. Determine if product or claim changes affect the 510(k) and advise Company of regulatory responsibilities. Continually evaluate FDA regulatory climate and requirements/policies and advise Company of regulatory matters' affect on the business. Advise individuals/groups within Company of Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Good Clinical Practice (GCP) and Investigational Device Exemption (IDE) regulations and related FDA policies and requirements. Review clinical investigational plans, IDEs and Medical Device Reports (MDRs) for adequacy and regulatory compliance. Review and approve advertising, labeling and product specification change requests. Evaluate regulatory status of new venture and/or OEM companies and provide recommendations to Company. Participate and represent Company and/or Johnson & Johnson Corporate on trade association task forces and programs.

InterVascular, Inc. (Datascope Corp.) 7/86-8/87

• Class II & III implantable cardiovascular devices
• Director of Regulatory Affairs

Company FDA liaison. Responsible for all regulatory submissions including IDEs, Premarket Approval Applications (PMAAs) and 510(k)s and supplements. Design and implement all preclinical testing. Develop protocols, create and manage computer databases for clinical studies and product traceability. Work closely with and coordinate many of the Quality Assurance activities. Perform all internal, contract vendor and contract sterilizer audits to ensure full compliance with GMPs. Process and respond to all product complaints and file MDRs. Work with more than 25 international distributors and Health Ministries in meeting the regulatory requirements to export devices. Provide technical assistance to physicians and sales representatives. Procure, review, and maintain all technical journals, papers and product information.

Coburn Optical Industries, Inc. (Storz Ophthalmics, Inc.) 3/82-7/86

• Class III intraocular lenses
• Class III ophthalmic laser
• Class II ophthalmic devices
• Regulatory Affairs Specialist 1986
• Clinical Monitor 1982-1986

Development of protocols for pre-clinical testing of new materials and products. On-going coordination and monitoring of clinical studies including the establishment and conduction of instructional sessions for investigators and sales representatives. Analysis of clinical studies data and results. Preparation of IDEs, PMAAs and 510(k)s. Process and respond to product complaints. Respond to physician and sales representative technical and regulatory inquiries. Advise manufacturing personnel of GMP requirements and conduct routine audits. Conduct special short-term research projects. Supervise secretarial and clerical personnel. Review and maintain all professional and technical journals.

PROFESSIONAL ACCOMPLISHMENTS

• Represent Regulatory Affairs on new product development teams providing more timely and better-defined regulatory requirements and FDA submission strategies resulting in higher-quality FDA submissions.
• Developed expertise in good software development, validation and documentation practices and participated in the development of R&D software development procedures; Represented Johnson & Johnson on Health Industry Manufacturers' Association (HIMA) Software Task Force; Presented on software-driven medical device submissions and software design controls at various professional conferences, including HIMA/FDA, Barnett International and Medical Design and Manufacturing.
• Developed company-wide training programs, including general regulatory requirements, process validation and design controls and preproduction quality assurance.
• Developed guidelines and processes to ensure consistent and timely review of labeling, advertising and specification change requests.
• Participated on the regulatory team for the IDE and one of the first PMAs for an ophthalmic specialized laser.
• Developed and implemented a total GMP program which resulted in a successful FDA establishment inspection.
• Presented on software design controls, FDA software submissions, and other regulatory requirements at numerous industry and professional conferences including:
  • HIMA/FDA Software Conferences
  • Barnett/Parexel International Educational Conferences
  • Canon Communications Medical Design and Manufacturing (MDM) East/West Conferences
• Lead instructor for AAMI/FDA Design Control Requirements and Industry Practice; Instructor for AAMI/FDA GMP/QSR Requirements and Industry Practice course.

EDUCATION

University of South Florida; Tampa, Florida:
BAs/Biology (1977) and Secondary Education (1978), cum laude
BA/Microbiology (1979)
AA/General Education (1975)

PROFESSIONAL SOCIETIES

Regulatory Affairs Professionals Society (RAPS); Regulatory Affairs Certified (RAC)
American Society for Quality (ASQ)

SPECIALIZED TRAINING

Software Validation to Satisfy FDA and ISO Guidelines - Computer Application Specialists
Software, the FDA and Your Medical Device - Malloy, Noblitt & Rueland
GMP Requirements and Industry Practice - AAMI and FDA
Design Control Requirements and Industry Practice - AAMI and FDA
Process Validation Concepts and Applications - Thibeault & Associates
Design Control and Quality Assurance - Thibeault & Associates
A Systems Approach to Project Management- Cambridge Consulting
Food & Drug Law - Stat-A-Matrix
Good Clinical Practices - Institute for Applied Pharmaceutical Sciences
Export Administration Regulations, Export Controls & Licensing - US Dept. of Commerce
Statistics - St. Petersburg Junior College
Influence Management - Forum Corporation
Manager & the Law - Johnson & Johnson
Coaching & Counseling Minority Professionals - Coleman Management Consultants

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