Project Management Regulatory Affairs

Betty Kao

Email: ********@*****.***

Text: 480-***-****

Objective

Dynamic and results-driven regulatory affairs professional with a Ph.D. in Biomedical science and PMP certification, seeking a remote leadership opportunity. Offering extensive experience in regulatory strategy, project management, and cross-functional team leadership within the medical device industry. Passionate about ensuring compliance and fostering innovation in product development.

Education & Certifications

Ph.D. in Biomedical Engineering, University of Queensland, Brisbane, Australia, 2015

M.Sc. in Biomedical Engineering, National Chiao-Tung University, Taiwan, 2006

Project Management Professional (PMP), Project Management Institute, Issued 2014

Food handling management, 2021

Food handling, 2019

ISO 13485:2016 & 19011:2018 Lead Auditor, Axeon, 2020

MDSAP/ISO 13485 Internal Auditor, Axeon, 2020

Medical Devices: US and EU Regulation, RAPS Online University, 2020

Drug Completion Course, UC San Diego (Coursera)

Professional Experience

Regulatory Affairs

BICO, AZ Aug 2021 - May 2022

Led regulatory strategy for Class III knee replacement implant development, ensuring compliance with FDA and international regulations.

Collaborated across teams to address regulatory requirements and supported new product development initiatives.

Conducted training sessions and product demonstrations, fostering strong relationships with clients and stakeholders.

Produce Manager

99 Ranch, AZ Feb 2021 – Aug 2021

Ensure Compliance: Oversee and enforce adherence to all regulatory guidelines, including FDA, USDA, and local food safety standards for produce operations.

Vendor Coordination: Manage vendor relationships to ensure timely delivery, quality assurance, and compliance with safety and quality standards.

Audit and Reporting: Conduct regular audits and inspections, maintaining detailed records to meet regulatory requirements and address any compliance concerns.

Regulatory Affairs Lead & Business Owner

Braxx Biotechnology, LLC, AZ Feb 2021 - Dec 2022

Developed and maintained up-to-date knowledge of relevant regulations to ensure compliance and avoid penalties.

Built and managed relationships with regulatory agencies, facilitating regular communications to discuss products and compliance.

Promoted a culture of quality and compliance within the organization, ensuring the safety and efficacy of products.

Regulatory Affairs

Beckson Dickson (BD), AZ May 2018 - Dec 2020

Managed compliance for Class I, II, and III medical devices across the US, EU, and Greater China.

Coordinated regulatory submissions and responses, leveraging in-depth knowledge of local and international regulations.

Led the planning and execution of pre- and post-market regulatory strategies, ensuring alignment with business goals.

Scientist / Project Manager

Mayo Clinic, Purdue University, ECU, US July 2015 - May 2018

Directed multiple research projects, mentoring PhD students and staff in regulatory compliance and project execution.

Ensured adherence to GxP regulations and actively participated in clinical trials, focusing on ICH and GCP guidelines.

Streamlined SOPs and regulatory documentation, enhancing quality and efficiency across research operations.

Scientist

Kaohsiung Medical University, Taiwan 2002-2004; 2006-2009; 2012-2015

Assisted in regulatory compliance and customer service functions, addressing inquiries with professionalism and accuracy.

Conducted training and development sessions, enhancing team capability in regulatory affairs and compliance.

Skills

Regulatory Affairs: Expertise in FDA regulations, ISO standards, and medical device compliance.

Project Management: Proficient in project planning, execution, and cross-functional collaboration.

Research & Development: Strong background in biomedical research, data analysis, and report generation.

Communication: Bilingual proficiency in Mandarin and English, with excellent presentation skills.

Technical Proficiency: Familiarity with biomedical engineering concepts and relevant software tools.

Publications & Presentations

Over 15 peer-reviewed publications, including studies on mitochondrial dysfunction and cancer research.

Conference presentations on topics related to mitophagy and cellular responses in stem cells.

Hobbies

Volunteer work at animal shelters, gardening, and community engagement.

Contact this candidate