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Jessica RAC

President, Regulatory Consultant

Director of Regulatory Affairs at pfm medical, inc.

Greater San Diego Area

Section title

Jessica RAC's Email Addresses & Phone Numbers

Jessica RAC's Work Experience

J Consulting Group

President, Regulatory Consultant

February 2013 to Present

Bard Access Systems (C.R. Bard)

Regulatory Affairs Specialist

May 2007 to February 2013

Jessica RAC's Education

San Diego State University-California State University

Advanced Certificate Regulatory Science

2007 to 2009

University of Utah

M.Ed. Education

2006 to 2007

University of Utah

M.A. Secondary Education

2005 to 2006

About Jessica RAC's Current Company

J Consulting Group

J Consulting Group works with multi-billion dollar medical device manufacturers as well as medtech start-ups to provide global regulatory expertise and product development support. Successfully working with clients in the following areas: - Global regulatory strategy development and implementation; - US FDA regulatory submission documentation including 510(k)s, PMAs, de novo classifications, and pre-submissions; - EU Technical Dossier...

About Jessica RAC

📖 Summary

President, Regulatory Consultant @ J Consulting Group works with multi-billion dollar medical device manufacturers as well as medtech start-ups to provide global regulatory expertise and product development support. Successfully working with clients in the following areas: - Global regulatory strategy development and implementation; - US FDA regulatory submission documentation including 510(k)s, PMAs, de novo classifications, and pre-submissions; - EU Technical Dossier submission documentation for Class I, II, and III devices; - International submission documentation for Asia, Latin America, South America, Canada, Australia, Middle East and various Emerging Markets; - US Agent Representation for foreign manufacturers; - EU Notified Body Technical File audit readiness; and - ISO 13485 and FDA audit preparation. Additionally, J Consulting Group attends relevant Professional Society meetings to maintain awareness of new scientific advancements and current therapies and to interact with investigators and key opinion leaders. From February 2013 to Present (2 years 11 months) Regulatory Affairs Specialist @ Responsible for implementation of domestic and international regulatory affairs procedures for PICCs, the largest franchise within C. R. Bard, and Medical Imaging. Specific responsibilities included: - Global regulatory strategy development and execution, including Regulatory Affairs planning for new products and pre-submissions; -Reviewed all design inputs, design validation, test protocols, test reports and risk assessments to ensure compliance to ISO Standards, FDA guidance documents and standard operating procedures throughout the entire product development cycle from concept phase through post market surveillance. Reviewed product labeling and marketing collateral to ensure regulatory compliance; -US FDA regulatory submissions and documentation, including Traditional and Special 510(k) premarket notifications and No 510(k) files. Interfaced with the FDA during 510(k) review process to facilitate successful clearances; - EU Technical Dossier submissions and documentation for Class I, II, and III products to obtain CE Mark. Interfaced with Notified Body during review process and act as the regulatory lead for successful on-site reviews; - International Dossier submissions for China, Brazil, Taiwan, Canada, Australia, Korea, and Mexico. Worked with in-country RA counterparts to ensure successful product approvals; - Supported design control and regulatory strategy and filing aspects of onsite FDA and Notified Body audits. Primary regulatory interface for multiple products during audit activities; - Regulatory lead for internal and external acquisitions of franchises with over $100M in combined global sales and more than 300 distinct configurations sold into all major markets including US, Canada, Australia, Europe and Asia. From May 2007 to February 2013 (5 years 10 months) Advanced Certificate, Regulatory Science @ San Diego State University-California State University From 2007 to 2009 M.Ed., Education @ University of Utah From 2006 to 2007 M.A., Secondary Education @ University of Utah From 2005 to 2006 B.S., Psychology @ University of Scranton From 1999 to 2003 Jessica RAC is skilled in: Medical Devices, FDA, Catheters, CE marking, Design Control, Quality System, Regulatory Affairs, Regulatory Submissions, Regulatory Requirements, PMA, Medical Device Directive, 21 CFR, 21 CFR Part 11, ISO 13485, CAPA


Jessica RAC’s Personal Email Address, Business Email, and Phone Number

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Frequently Asked Questions about Jessica RAC

What company does Jessica RAC work for?

Jessica RAC works for J Consulting Group


What is Jessica RAC's role at J Consulting Group?

Jessica RAC is President, Regulatory Consultant


What is Jessica RAC's personal email address?

Jessica RAC's personal email address is j****[email protected]


What is Jessica RAC's business email address?

Jessica RAC's business email addresses are not available


What is Jessica RAC's Phone Number?

Jessica RAC's phone (**) *** *** 792


What industry does Jessica RAC work in?

Jessica RAC works in the Medical Devices industry.


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Jessica RAC's Personality Type

Extraversion (E), Intuition (N), Feeling (F), Judging (J)

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