Psychotherapy

Theresa M. Mitchell.

******@*****.***

NPI # 157*******

MI License # 636-***-****:

SUMMARY OF QUALIFICATIONS

Crisis Intervention, Cultural Competency, Evidence, Psychosocial, Psychotherapy, Record Keeping

Education: B.A. Experimental Psychology/Biostatistics, California State University S.F., Liberal Arts/Master of Arts (LAMA) Experimental Psychology Program, California State University, San Francisco, CA

MA Clinical Psychology, CIIS, San Francisco, CA

Psy D. California Institute of Integral Studies (CIIS) ABD

Hypnotherapist, Hypnotherapy Institute, Santa Rosa, CA. 2011

Healthcare industry veteran of 20 + years; have held senior executive positions in nearly every aspect of the corporate structure, including Operations, Business Development, Domestic and International Regulatory & Clinical Affairs, Quality Assurance and Research & Development; participated in numerous public offerings, acquisitions, creation of new business units.

I have a proven track record with FDA and International Regulatory agencies and excellent knowledge of FDA, ICH, GCP Guidelines; Expert at clinical research design and methodology

--- Blue Water Counseling Port Huron, MI 48060, 5/2023 -current

Treating adults, couples, children

1501 Krafft Rd.

--GLIO Counseling Oxford, MI. 9/2022- August 2023)

Currently seeing individuals, couples, youths

826 S. Lapeer Rd., Oxford, MI

--Community Psychotherapy Center; provide psychotherapy to adults, couples children.

-Community Institute for Psychotherapy-Intern (CIP )

1330 Lincoln Ave. San Rafael, 94901 415-***-**** x4

--Previous:

June, 2015- 2016, Telecare ACT Sonoma; community outreach to severely and persistently mentally ill adults. //individual & group therapy (Art Group)

College Ave., Santa Rosa, CA

2014-2015

BAART (Bay Area addiction, research and Treatment) Outpatient Methadone Treatment program.

January -2011-2013 Consultant to the Healthcare Industry

Recent projects include a medical imaging and therapeutic technology and a continuous glucose monitoring device.

Nellix, Inc. Jan 1, 2009-Dec 31, 2011 (acquired by Endologix, Inc.) Vice-president Operations, Regulatory Affairs, Clinical Research, Chief Compliance Officer

Nellix developed an original device designed to address and expand the indication for the less invasive treatment of Abdominal Aortic Aneurysms (AAAs) and Thoracic Aortic Aneurysms (TAAs) • Act as liaison to FDA and European and Asian Regulatory Agencies; Manage Scientific Advisory Board, Corporate Communication; Manufacturing, Quality Assurance, Project team leaders.

• Managed quality crisis resulting in successful audit for California State Manufacturing License and ISO Audit.

•Supported the CEO in restructuring of organization and implementation of Project Teams to facilitate communication and improve product development.

• Assumed marketing role in absence of permanent hire, managed conference schedule, presentations, and marketing materials, live case presentation.

•Managed the facility, maintenance, security, renovation, etc. CER and monitoring, Inventory Control, Purchasing, manufacturing processes and procedures, COGS.

Led International clinical trials.

Participated on ISO panel to set standards for medical devices.

Fox Hollow Technologies, Inc. (acquired by EV3) Jan 2007 – January 2008 Vice-President Regulatory & Clinical Affairs

• Cardio-peripheral vascular company with well-established leadership in plaque excision technology.

• As VP, oversee management of both Regulatory and Clinical functions; lead the strategic activities of RA/CA programs to meet corporate goals, lead design and execution of studies to support marketing, reimbursement, and regulatory submissions (IDE, 510k, PMA products); initiated relationship with FDA and OUS agencies.

• Lead the tactical activities of RA/CA programs to achieve departmental goals, lead design and execution of studies, investigator and site selection, initiated relationship with FDA and OUS agencies. Restructured the organization to develop and retain the highest quality team.

• Worked closely and cooperatively with other functional areas, SAB members, key physicians.

Oculus Innovative Sciences, Inc. Jan 2005 – Jan 2007

Vice-President Regulatory and Clinical Affairs, Quality Assurance, Research & Development

• Technology based on Electrolyzed water as a platform for both device and pharmaceutical use. Initial applications focused on wound care; management of infected wounds; topical antimicrobial characteristics; follow on applications in respiratory, cardiovascular, and other medical markets.

• Obtained original FDA clearances in extremely short period of time.

• Managed Quality Operations at Domestic and International manufacturing facilities.

• Developed and received positive findings from FDA for clinical protocols on “open wound” applications to gain pharmaceutical claim

• Managed International Regulatory agencies to obtain approvals in dozens of countries and received CE mark approval. Managed ISO 13485 facility and Research & Development team that includes Medical Director, Director of R&D, Director of New Product Development, and basic science group.

ORATEC Interventions, Inc., (acquired by Smith-Nephew) Menlo Park, CA Dec 1999 – Dec 2004

Vice President, Regulatory and Clinical Affairs and Quality Assurance

• Responsible for the planning, conduct, and management of regulatory and quality projects in support of the company’s strategic plan, provide strategic input and develop regulatory strategies, lead the development of pre-clinical and clinical study protocols, make key decisions regarding rules and regulations in order to move approvals along at a rapid pace while still maintaining the highest level of quality.

• In conjunction with other executives develop strategic plan for the company, while applying knowledge of regulatory affairs and quality assurance to assist the company in developing a strategic plan for the development of new products.

• Major duties include: Act as primary liaison with FDA and international regulatory authorities.

• Review and interpret regulatory rules and ensure the communication of these policies and procedures is distributed throughout the company.

• Review and approve Clinical Investigational Plans and Institutional Review Board submissions.

• Review all data prior to submission to FDA.

• Review all product labeling and marketing materials to ensure compliance with worldwide regulatory requirements.

• Review and approve all changes to manufacturing processes to ensure compliance with FDA and Quality Systems guidelines.

• Ensure that all regulatory and internal policies are followed.

• Develop clinical studies strategy to achieve reimbursement for product/procedure in the U.S. and International markets.

• Actively participated in the Initial Public Offering (IPO) activities, due diligence, etc.• Participated on acquisition team for sale of company to Smith & Nephew.

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