
Rac Julia Anastas
I am a collaborative and innovative leader with a unique mix of strategic, technical and operational capabilities gained... | San Francisco Bay Area, San Francisco Bay Area, United States
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Rac Julia Anastas’s Emails ja****@si****.com
Rac Julia Anastas’s Phone Numbers No phone number available.
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Rac Julia Anastas’s Location San Francisco Bay Area, San Francisco Bay Area, United States
Rac Julia Anastas’s Expertise I am a collaborative and innovative leader with a unique mix of strategic, technical and operational capabilities gained from over 20 years of regulatory, clinical, quality, and laboratory experience in the medical device industry. This experience allows me to think cross-functionally. I am able to capitalize on interpersonal skills to build robust, team-supported regulatory strategies, product submissions, and compliant post-market follow-up programs. I’ve worked in small, mid-size, and large healthcare organizations across a wide range of therapy applications including peripheral vascular, cardiovascular, pulmonology, bariatrics, diabetes, reproductive medicine, and IVDs. My career has had particular focus on development of regulatory and clinical strategies, and negotiations for PMA and IDE-level products, such as FDA Advisory Committee meetings, Office of Device Evaluation presentations, and Notified Body (CE Mark) interactions. I am recognized for establishing trust across teams and with regulators, and producing results through clear and honest communication, truly listening to feedback / input. This in turn allows me to develop appropriate strategies and deliver team accountability with predictable outcomes for the business. My areas of expertise comprise: Strategic Planning Team Building Organizational Leadership Regulatory Submissions Regulatory Negotiations Clinical Research Regulatory Compliance Quality Systems External Audits Procedure Development Interventional Therapies Implantable Devices Active Devices
Rac Julia Anastas’s Current Industry Silk Road Medical
Rac
Julia Anastas’s Prior Industry
Abbott
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Vibrynt
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Experien
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Auxogyn
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Btg
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Silk Road Medical
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Work Experience

Silk Road Medical
Vice President, Regulatory Affairs
Sun Mar 01 2020 00:00:00 GMT+0000 (Coordinated Universal Time) — Present
Btg
Vice President, Regulatory Affairs
Thu Feb 01 2018 00:00:00 GMT+0000 (Coordinated Universal Time) — Sun Dec 01 2019 00:00:00 GMT+0000 (Coordinated Universal Time)
Btg
Director, Regulatory Affairs
Thu Jan 01 2015 00:00:00 GMT+0000 (Coordinated Universal Time) — Mon Jan 01 2018 00:00:00 GMT+0000 (Coordinated Universal Time)
Auxogyn
Director, Regulatory Affairs
Wed Jan 01 2014 00:00:00 GMT+0000 (Coordinated Universal Time) — Thu Jan 01 2015 00:00:00 GMT+0000 (Coordinated Universal Time)
Experien
Sr. Director, Regulatory Affairs
Tue Jan 01 2013 00:00:00 GMT+0000 (Coordinated Universal Time) — Wed Jan 01 2014 00:00:00 GMT+0000 (Coordinated Universal Time)
Vibrynt
Director, Regulatory Affairs
Tue Jan 01 2008 00:00:00 GMT+0000 (Coordinated Universal Time) — Sun Jan 01 2012 00:00:00 GMT+0000 (Coordinated Universal Time)
Abbott
Associate Director, Regulatory Affairs
Sun Jan 01 2006 00:00:00 GMT+0000 (Coordinated Universal Time) — Tue Jan 01 2008 00:00:00 GMT+0000 (Coordinated Universal Time)
Abbott
Manager, Regulatory Affairs
Sat Jan 01 2005 00:00:00 GMT+0000 (Coordinated Universal Time) — Sun Jan 01 2006 00:00:00 GMT+0000 (Coordinated Universal Time)
Abbott
Advisor, Regulatory Affairs
Thu Jan 01 2004 00:00:00 GMT+0000 (Coordinated Universal Time) — Sat Jan 01 2005 00:00:00 GMT+0000 (Coordinated Universal Time)
Abbott
Principal Associate, Regulatory Affairs
Tue Jan 01 2002 00:00:00 GMT+0000 (Coordinated Universal Time) — Thu Jan 01 2004 00:00:00 GMT+0000 (Coordinated Universal Time)