Cathy Stupak

Ventura, California, United States

ad0wff@r.postjobfree.com

linkedin.com/in/cathy-stupak-7ba6b38

Summary

Regulatory Specialist with experience in medical device regulations including extensive negotiations with FDA, EU Notified Bodies, and ROW Agencies. PMA Expert. Excellent organizational skills, effective at verbal and written communication. Conscientious, goal-oriented, team player. EDUCATION

Ph.D. in Physical Chemistry, Brandeis University, Waltham, MA B.S. in Chemistry, West Chester University, West Chester, PA ACHIEVEMENT

• RAC certified in US and EU.

• Former Chair of the local section of the American Chemical Society

• Former Chair of the American Vacuum Society Recommended Practices Committee.

• Physical Chemistry laboratory teaching award, Brandeis University. Experience

Regulatory Affairs Lead

Johnson & Johnson Vision

Sep 2022 - Jun 2023 (10 months)

Authored one 30-Day Notice for the PMA laser eye surgery console, and numerous LTFs for Class II devices. Worked remotely with internal teams and ROW on 2 manufacturung projects. Regulatory Specialist, Expert

Agilent Technologies

Aug 2017 - Sep 2022 (5 years 2 months)

Obtained FDA approval of PMA post-market submissions for IVD products, including one Manufacturing Site Change, four 30-Day Notices, and three Annual Reports. Responsible for RA Assessments, Regulatory Intelligence, and was the RA representative on change teams. Worked remotely for 1 year and 10 months.

Contract Regulatory Affairs Specialist

Biosense Webster

2016 - Aug 2017 (1 year)

Authored and obtained approval of three 30-Day Notices for AFIB Cardiovascular Catheters, fulfilling my contract. Completed a 8665-page submission (28 binders) in 20 calendar days. Sr. Regulatory Affairs Specialist

Advanced Bionics

Sep 2012 - 2016 (4 years)

Cathy Stupak - page 1

Obtained approval of multiple cochlear implant PMA Supplements, Annual Reports and Pre- Submissions. Created work instructions and checklists to comply with FDA and Health Canada Regulations. Modified external standards process to be efficient and effective. Manager of Regulatory Affairs

Sientra, Inc.

Jan 2010 - Sep 2012 (2 years 9 months)

Helped to achieve FDA approval for a silicone gel-filled breast implant. Oversaw Regulatory Affairs Department. Managed submissions and timelines. Maintained regulatory documentation. Principal Regulatory Affairs Specialist

Boston Scientific

2007 - Dec 2009 (2 years)

Obtained neurostimulator approvals in EU, Australia, Korea, and Taiwan. Authored IDE, Annual Reports, and PMA Supplements. Responsible for unrestricting order entry in SAP. Sr. Regulatory Affairs Specialist

Advanced Bionics

2003 - 2007 (4 years)

Authored the PMA and achieved approval for the Precision Neurostimulator. Authored Annual Report for cochlear implant PMA. Obtained cochlear implant approvals in China, Taiwan, Singapore, Brazil, Colombia, and many other coutries. Assisted with cochlear implants MDRs. Sr. Regulatory Specialist

Computermotion

2001 - 2003 (2 years)

Authored several 510(k)s, and IDEs, and numerous IDE Supplements. Achieved Canadian approvals. Change board representative.

Regulatory Affairs Specialist

ACMI

2000 - 2001 (1 year)

Authored six 510(k)s, supervised four others. Achieved IDE approval. Supervised and trained junior- level specialists.

Regulatory Specialist

McGhan Medical / Inamed

1996 - 2000 (4 years)

Helped to achieve FDA approval for a saline-filled breast implant. Founding Member of the Los Padres Section of the American Chemical Society. Sales Engineer

HP

1992 - 1996 (4 years)

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Demonstrated operation of chemical analytical instruments. Education

Brandeis University

Ph.D., Physical Chemistry

1977 - 1983

West Chester University of Pennsylvania

B.S., Chemistry

1973 - 1977

Skills

FDA • 510 K • Regulatory Affairs • PMA • Medical Devices • CE marking • Regulatory Submissions • Regulatory Strategy • Technical Writing • IDE Cathy Stupak - page 3

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