Anette has been an independent regulatory affairs consultant since 1998. Prior to consulting, she was Director, Regulatory Affairs, for Critikon, a Johnson & Johnson Company, where she worked with cardiovascular monitoring devices since 1987. She has over 20 years experience in regulatory affairs, compliance and clinical affairs with prior experiences in the implantable cardiovascular and ophthalmic devices industries. Her worldwide regulatory affairs responsibilities have included FDA submissions, GMP/QS compliance, interpretation of all FDA regulations and policies, regulatory representation on new product development teams, product liability and international product registrations. She has also represented Johnson & Johnson on several software related FDA/industry guidance and standards-setting activities.
Ms. Hillring is Regulatory Affairs Certified and holds BA degrees in biology, microbiology and secondary science education.