The voting period has closed. The New Board Members will be announced soon.
Since February 2024, I have progressively taken on more responsibilities in serving the OCRA community. My key contributions include:
I hope to give back to OCRA what I have gained from it. From a student in regulatory science to a junior professional, OCRA has been pivotal in my journey. It has provided invaluable networking opportunities with senior RA professionals, access to free educational resources, and connections with dedicated community builders. My goal is to ensure that OCRA members experience the same sense of community, high-quality educational resources, and a robust platform for opportunities and networking. I am committed to fostering an environment where members can grow, learn, and connect just as I have.
I have been a member of OCRA for most of the last 20 years. Currently taking a course for International Board Director Competency Designation (IBDC.D) to obtain Certification through M. A. Pfister Strategy Group’s Board certification program.
I would love to be more active in a Board Director role with OCRA and happy to share all of my knowledge and experience within all areas of the Organization.
With a strong focus in Strategy, Governance, & Risk/Compliance, Shelly Gallup is a high-achieving Quality Assurance & Regulatory Affairs Expert in the Medical Device and In-Vitro Diagnostic industry. She has demonstrated success in managing positive interactions with regulatory agencies, both domestically and internationally, bringing product to market. Throughout her career, Ms. Gallup has developed a wealth of knowledge related to the lifecycle management of multiple product types, considered low to high patient risk. She prides herself on enabling people to think differently and initiating meaningful shifts in what people think is important and directing those minds toward the goal with discipline and transparency.
The overarching theme throughout her career has been her propensity in leadership positions, passion on self-development and developing others, mentoring and coaching, and ability to create value for shareholders and stakeholders through creative, out-of-the-box regulatory strategies. In addition, Ms. Gallup has received a “Bold Moves & Rising Stars” spotlight in the Spring 2024 edition of The LEAD Magazine.
I volunteered at the recent annual OCRA conference alongside current board members. My responsibilities included emailing potential sponsors for partnerships, interviewing speakers, managing room traffic, and assisting with setup and cleanup. Additionally, I volunteered at the OCRA table during the RAPS Convergence in Long Beach. I am also actively working as part of the Education Committee to bring educational speakers to our OCRA members.
I have worked in a translational research lab for over 10 years and recently graduated with a Master’s in Medical Product Quality from USC. I am involved in developing potential treatments for osteoarthritis, with some currently advancing to clinical trials. I collaborate with multiple departments and organizations. I also mentor undergraduate and master’s students on their research projects.
I am highly organized, detail-oriented, and dedicated to completing tasks efficiently. My experience working with OCRA board members at several events has improved my ability to work well within teams. OCRA members come from a wide range of backgrounds and career paths. I believe I can bring a unique perspective and contribute to maintaining the quality and inclusivity of the organization’s programs.
In the past year I have been a panelist for one of OCRA’s educational talks, helped advertise and brought in sponsorship for the OCRA annual conference, and acted as the social committee chair with other board members to promote, plan and attend social hours and activities for members. I have also helped out with dine around events during the RAPs convergence and assisted in representing OCRA at medical conferences and events.
I hope to bring consistency in events, update to date information and a larger outreach of OCRA’s presence and capabilities to the greater Southern California community. I feel that with the current board and momentum of 2024 I am able to help foster increase membership and member satisfaction with consistent ROI for those being apart of the organization.
My experience as ‘Voice of Client’ is valuable to my customers as they do not report to our offices on a daily basis. The interactions I have with them as well as our engineering staff maintains open communication, and helps focus all efforts to achieve project goals. This type interaction would be beneficial to any members of the OCRA community.
I have been a member of OCRA for most of the last 20 years. Currently taking a course for International Board Director Competency Designation (IBDC.D) to obtain Certification through M. A. Pfister Strategy Group’s Board certification program.
I would love to be more active in a Board Director role with OCRA and happy to share all of my knowledge and experience within all areas of the Organization.
With a strong focus in Strategy, Governance, & Risk/Compliance, Shelly Gallup is a high-achieving Quality Assurance & Regulatory Affairs Expert in the Medical Device and In-Vitro Diagnostic industry. She has demonstrated success in managing positive interactions with regulatory agencies, both domestically and internationally, bringing product to market. Throughout her career, Ms. Gallup has developed a wealth of knowledge related to the lifecycle management of multiple product types, considered low to high patient risk. She prides herself on enabling people to think differently and initiating meaningful shifts in what people think is important and directing those minds toward the goal with discipline and transparency.
The overarching theme throughout her career has been her propensity in leadership positions, passion on self-development and developing others, mentoring and coaching, and ability to create value for shareholders and stakeholders through creative, out-of-the-box regulatory strategies. In addition, Ms. Gallup has received a “Bold Moves & Rising Stars” spotlight in the Spring 2024 edition of The LEAD Magazine.
I started in Life Sciences 40 years ago, and have worked in both the pharmaceutical and medical device industries. I established an independent regulatory consultancy 20+ years ago, supporting drug companies seeking the 506(b)(2) approvals and medical device companies seeking PMA, De Novo and 510(k) submissions. I enjoy speaking and teaching, with a goal of providing insights for regulatory success for beneficial products.
Since February 2024, I have progressively taken on more responsibilities in serving the OCRA community. My key contributions include:
I hope to give back to OCRA what I have gained from it. From a student in regulatory science to a junior professional, OCRA has been pivotal in my journey. It has provided invaluable networking opportunities with senior RA professionals, access to free educational resources, and connections with dedicated community builders. My goal is to ensure that OCRA members experience the same sense of community, high-quality educational resources, and a robust platform for opportunities and networking. I am committed to fostering an environment where members can grow, learn, and connect just as I have.