Connie Hertel

Connie Hertel boasts over 30 years of experience in the medical device and IVD Regulatory Affairs and Quality Assurance field.

Throughout her career, she has excelled in preparing, submitting, and consulting on Product Regulatory Submissions and EU Technical Files.

Connie has a diverse background, having worked in both small start-up companies where she was instrumental in implementing RA/QA systems and large corporate companies, some of which had acquisitions.

As a Certified Lead Assessor, she has conducted over 200 company audits for two registrars, highlighting her expertise in regulatory compliance and quality standards.

She has played a pivotal role in handling Pre and Post Market regulatory programs and has collaborated closely with product development teams and risk assessment teams.

Connie Hertel also served as the primary contact for interactions with regulatory bodies like the FDA and Notified Body, showcasing her adeptness in navigating regulatory landscapes.

She pursued her undergraduate studies at Northeastern University, where she studied for a Bachelor of Science degree.

Currently, Connie holds the position of Regulatory and Quality Consultant at Respiratory Motion, Inc., bringing her wealth of experience and knowledge to the organization.

Previously, she held the position of Senior Regulatory Specialist at St. Jude Medical, further solidifying her expertise in the regulatory and quality realm.