"I worked closely with Golddy while she was leading Clinical Validation initiatives for innovative technology, TULSA-PRO, at Profound Medical.
Golddy had a remarkable approach to setting up all aspects of clinical research, managing complex clinical advisory board interactions, and ensuring meticulous attention to detail while designing the clinical trial.
Her strategic approach and deep understanding of clinical research processes made her an invaluable team lead. Golddy's professional capabilities extend beyond executing clinical trials.
She possesses a comprehensive understanding of intricacies involved in bringing innovative medical technologies from concept to clinical validation to commercialization.
Her work has been instrumental in advancing medical research and supporting innovative medical technologies."
I interacted with Golddy during the development of the TACT Clinical Trial strategy.
She demonstrated an extraordinary depth of knowledge of Medical Device Investigation Regulation.
Her ability to anticipate potential challenges was truly remarkable.
She consistently thought 10 steps ahead, which can impact project outcomes.
She managed uncertainty with a remarkable sense of calm and purposefulness.
She spoke with conviction in boardroom discussions and articulated her messages well.
She brings considerable value to any complex clinical and regulatory initiative.
I worked with Golddy during the TACT clinical trial and for the Usability Study.
Her responsiveness and supportive approach helped get through the crucial phases of contracts and budgeting approvals.
Her collaborative leadership style and ability to build trust were evident — as she guided the team through to treating the patients.
She led the trial admirably and was the key person to enabling multiple sites, timely enrollment and completion of the trial on time.
Golddy, I've enjoyed all our interactions.
And your track record of steering the TULSA-Pro system to successful FDA approval speaks for itself.
I recall back when we formed Profound Medical.
Many people were skeptical that the FDA would permit a closed-loop technology to get through as a Class III device.
And you proved them wrong!
Golddy is an exceptional industry leader who is passionate about bringing scientific research to the patient's bedside. She is distinguished by her remarkable ability to navigate complex partnerships between universities, hospitals, and industry leaders. Her strategic approach and commitment to overcoming challenges make her an invaluable partner in advancing scientific knowledge.
Her persistent problem-solving abilities to maintain strong relationships across different environments is remarkable. She approaches potential roadblocks with creativity and determination, ensuring that collaborative projects continue to progress effectively.
She was instrumental in bringing our MR-HIFU research project on pediatric bone tumor treatment through the FDA HDE approval, which was a huge achievement that wouldn't have happened without her leadership. Golddy can bridge different cultures while maintaining a laser-focused commitment to science and technology advancement.
If you were to encounter regulatory challenges in clinical trials, Golddy is someone you need to have under speed dial number 1.
She will listen to you, explain the issues to you and most importantly, simplify complex regulatory / clinical questions into executable solutions.
Trust her.
She will chart a course for your success.
Golddy's passion for clinical research was evident when she approached us for setting the Clinical Trial for TULSA-PRO.
Her comprehensive understanding of the scientific, regulatory, and contractual landscape is truly remarkable.
She navigated the complexities of legal entities involved in this trial with incredible efficiency and expertly managed the budgets.
Her communication skills made collaboration seamless across all levels.
Her ability to bring people together and drive the project forward was impressive.
She knows how to be efficient while respecting others involved in the process.
Golddy possesses a rare combination of regulatory expertise and an in-depth understanding of the MedTech industry. Her strategic insights were critical in ensuring our product development processes aligned seamlessly with regulatory requirements and business objectives. This alignment not only enabled us to tackle complex challenges with confidence but also helped us avoid significant delays and unnecessary costs.
Her ability to anticipate regulatory hurdles and proactively address them saved us both time and resources. Golddy’s sharp focus, extensive knowledge, and pragmatic approach are invaluable to any MedTech company aiming to bring innovative products to market efficiently and compliantly.
I had the privilege of working with Golddy at Profound Medical for three years and have been in the MedTech field for many years myself. Her work consistently stands out for its quality and impact. Golddy is truly an asset to any organization seeking to navigate the complexities of the MedTech landscape.
I'm pleased to share my working experience with Golddy!
She truly stands out for her exceptional leadership qualities. Her curious mind drives her to explore innovative solutions, while her ability to remain calm under pressure allows the team to focus on what matters.
Golddy is a great listener who genuinely understands team dynamics, and her commitment to fair play creates a collaborative and respectful work environment.
Throughout our four years of working together, she demonstrated remarkable skills in balancing strategic direction with individual team member creativity. Her capability to navigate diverse cultural and educational backgrounds is particularly impressive. Golddy consistently delivers on time while focusing on a forward-thinking approach. She is a straightforward and exceptionally effective professional who focuses on the broader impact of her work.
I have had the pleasure of working with Golddy and learning from her over the past few years.
In all projects, she integrates strategy, technical expertise, and coaching skills to drive consensus among stakeholders and solve problems.
What I have personally experienced in our collaborations is Golddy’s ability to envision the end goal and think systematically to connect the dots between a vision and actions.
She brings patience and composure to complex, multi-stakeholder conversations.
I have found Golddy to be passionate, caring, and approachable.
She consistently goes above and beyond her commitments to provide support.
I worked with Golddy on several projects.
Her knowledge of MedTech Regulations and how they apply to an organization's stage and product is incredible.
She knows how to strike the right balance between business and compliance needs.
She is proactive, result-oriented, driven, energetic, and generous in allocating her time to mentor her team.
Golddy is a delight to work with.
Working alongside Golddy during the TULSA-PRO Product Development was a masterclass in excellence.
Her leadership in Regulatory and Clinical Affairs, paired with her strategic clarity and pragmatic approach, consistently turned challenges into opportunities.
She has an unmatched ability to deliver impactful results while fostering trust and alignment among stakeholders.
Golddy is a visionary strategist who makes a measurable difference—an invaluable asset to any organization.
Working for Golddy has been an exceptional experience.
Her expertise in medical device regulatory affairs is remarkable, and her deep understanding of the complexities of the industry is truly impressive.
Golddy consistently provides clear guidance, strategic solutions, and a results-driven approach that inspires confidence.
Her professionalism, attention to detail, and ability to navigate regulatory challenges make her an invaluable asset to any medical device company.
I highly recommend Golddy for her outstanding contributions and commitment to excellence.
I have worked with Golddy as part of a team, in a start-up organization, when we were trying to navigate our way towards scale-up and commercialization.
Golddy was instrumental in setting up the compass so we could establish direction and the tools required to reach destination.
Her knowledge, experience and effective analytical skills helped shape the strategy for a successful outcome.
I am grateful to have had the opportunity to work for Golddy at Profound Medical.
Golddy is a true leader who uplifts individuals and identifies their true potential.
She recruited me after I approached her through LinkedIn, offering me a chance to grow and learn under her guidance.
In addition to being a supportive mentor, Golddy is very well-versed in the field of complex regulatory filings, showcasing her expertise and knowledge in the industry.
Golddy's mentorship has been instrumental in my professional development.
She is a leader who genuinely cares about providing opportunities and support, even to complete strangers.
Her ability to inspire and guide others is truly commendable.
I worked closely with Golddy during the Sonalleve acquisition due diligence process.
Her ability to quickly grasp complex products and confidently navigate the intricacies of the regulatory landscape was truly impressive.
She possesses exceptional communication skills, articulating complex issues with remarkable clarity to both internal and external stakeholders.
She is a person of integrity and high ethical standards.
I enjoyed working with her, and I would recommend her as a highly competent Quality & Regulatory professional.
I worked with Golddy from 2005 to 2007 while she served as the Quality Manager on my team at XLTEK (now Natus). Peers in our organization expressed skepticism at my hiring decision, commenting, "Why are you hiring Golddy? She's such a strong Quality professional; she'll replace you someday!" My response was simple, "That's precisely why I chose to hire her!".
Golddy proved to be a dedicated and innovative team member, consistently seeking ways to enhance and refine our Quality Management System. Her strengths included creativity, curiosity, open-mindedness, and a strong focus on achieving goals.
When I left XLTEK in 2007 to pursue a different chapter in my career, I trusted Golddy was going to be more than capable of taking on my position. Since then, I have observed her successes and admire her incredible growth.
She has evolved into a highly regarded MedTech QA/RA/Clinical expert, demonstrating mastery through hard work and dedication. I highly recommend her services!
Working alongside Goldy was an invaluable learning experience. Her profound understanding of the industry, honed through years of experience in major corporations, combined with her ability to navigate the unique challenges of a startup environment, was truly remarkable.
She possesses a rare talent for seeing the broader strategic landscape, providing clarity and direction even in the most complex situations.
Beyond her expertise, she has a gift for recognizing and nurturing the potential in others, empowering them to understand their own value and contributions.
I wholeheartedly recommend her to any organization seeking strategic insight and impactful leadership.
"I worked closely with Golddy while she was leading Clinical Validation initiatives for innovative technology, TULSA-PRO, at Profound Medical.
Golddy had a remarkable approach to setting up all aspects of clinical research, managing complex clinical advisory board interactions, and ensuring meticulous attention to detail while designing the clinical trial.
Her strategic approach and deep understanding of clinical research processes made her an invaluable team lead. Golddy's professional capabilities extend beyond executing clinical trials.
She possesses a comprehensive understanding of intricacies involved in bringing innovative medical technologies from concept to clinical validation to commercialization.
Her work has been instrumental in advancing medical research and supporting innovative medical technologies."
I interacted with Golddy during the development of the TACT Clinical Trial strategy.
She demonstrated an extraordinary depth of knowledge of Medical Device Investigation Regulation.
Her ability to anticipate potential challenges was truly remarkable.
She consistently thought 10 steps ahead, which can impact project outcomes.
She managed uncertainty with a remarkable sense of calm and purposefulness.
She spoke with conviction in boardroom discussions and articulated her messages well.
She brings considerable value to any complex clinical and regulatory initiative.
I worked with Golddy during the TACT clinical trial and for the Usability Study.
Her responsiveness and supportive approach helped get through the crucial phases of contracts and budgeting approvals.
Her collaborative leadership style and ability to build trust were evident — as she guided the team through to treating the patients.
She led the trial admirably and was the key person to enabling multiple sites, timely enrollment and completion of the trial on time.
Golddy, I've enjoyed all our interactions.
And your track record of steering the TULSA-Pro system to successful FDA approval speaks for itself.
I recall back when we formed Profound Medical.
Many people were skeptical that the FDA would permit a closed-loop technology to get through as a Class III device.
And you proved them wrong!
Golddy is an exceptional industry leader who is passionate about bringing scientific research to the patient's bedside. She is distinguished by her remarkable ability to navigate complex partnerships between universities, hospitals, and industry leaders. Her strategic approach and commitment to overcoming challenges make her an invaluable partner in advancing scientific knowledge.
Her persistent problem-solving abilities to maintain strong relationships across different environments is remarkable. She approaches potential roadblocks with creativity and determination, ensuring that collaborative projects continue to progress effectively.
She was instrumental in bringing our MR-HIFU research project on pediatric bone tumor treatment through the FDA HDE approval, which was a huge achievement that wouldn't have happened without her leadership. Golddy can bridge different cultures while maintaining a laser-focused commitment to science and technology advancement.
If you were to encounter regulatory challenges in clinical trials, Golddy is someone you need to have under speed dial number 1.
She will listen to you, explain the issues to you and most importantly, simplify complex regulatory / clinical questions into executable solutions.
Trust her. She will chart a course for your success.
Golddy's passion for clinical research was evident when she approached us for setting the Clinical Trial for TULSA-PRO.
Her comprehensive understanding of the scientific, regulatory, and contractual landscape is truly remarkable.
She navigated the complexities of legal entities involved in this trial with incredible efficiency and expertly managed the budgets.
Her communication skills made collaboration seamless across all levels.
Her ability to bring people together and drive the project forward was impressive.
She knows how to be efficient while respecting others involved in the process.
Golddy possesses a rare combination of regulatory expertise and an in-depth understanding of the MedTech industry. Her strategic insights were critical in ensuring our product development processes aligned seamlessly with regulatory requirements and business objectives. This alignment not only enabled us to tackle complex challenges with confidence but also helped us avoid significant delays and unnecessary costs.
Her ability to anticipate regulatory hurdles and proactively address them saved us both time and resources. Golddy’s sharp focus, extensive knowledge, and pragmatic approach are invaluable to any MedTech company aiming to bring innovative products to market efficiently and compliantly.
I had the privilege of working with Golddy at Profound Medical for three years and have been in the MedTech field for many years myself. Her work consistently stands out for its quality and impact. Golddy is truly an asset to any organization seeking to navigate the complexities of the MedTech landscape.
I'm pleased to share my working experience with Golddy!
She truly stands out for her exceptional leadership qualities. Her curious mind drives her to explore innovative solutions, while her ability to remain calm under pressure allows the team to focus on what matters.
Golddy is a great listener who genuinely understands team dynamics, and her commitment to fair play creates a collaborative and respectful work environment.
Throughout our four years of working together, she demonstrated remarkable skills in balancing strategic direction with individual team member creativity. Her capability to navigate diverse cultural and educational backgrounds is particularly impressive. Golddy consistently delivers on time while focusing on a forward-thinking approach. She is a straightforward and exceptionally effective professional who focuses on the broader impact of her work.
I have had the pleasure of working with Golddy and learning from her over the past few years.
In all projects, she integrates strategy, technical expertise, and coaching skills to drive consensus among stakeholders and solve problems.
What I have personally experienced in our collaborations is Golddy’s ability to envision the end goal and think systematically to connect the dots between a vision and actions.
She brings patience and composure to complex, multi-stakeholder conversations.
I have found Golddy to be passionate, caring, and approachable.
She consistently goes above and beyond her commitments to provide support.
I worked with Golddy on several projects.
Her knowledge of MedTech Regulations and how they apply to an organization's stage and product is incredible.
She knows how to strike the right balance between business and compliance needs.
She is proactive, result-oriented, driven, energetic, and generous in allocating her time to mentor her team.
Golddy is a delight to work with.
Working alongside Golddy during the TULSA-PRO Product Development was a masterclass in excellence.
Her leadership in Regulatory and Clinical Affairs, paired with her strategic clarity and pragmatic approach, consistently turned challenges into opportunities.
She has an unmatched ability to deliver impactful results while fostering trust and alignment among stakeholders.
Golddy is a visionary strategist who makes a measurable difference—an invaluable asset to any organization.
Working for Golddy has been an exceptional experience.
Her expertise in medical device regulatory affairs is remarkable, and her deep understanding of the complexities of the industry is truly impressive.
Golddy consistently provides clear guidance, strategic solutions, and a results-driven approach that inspires confidence.
Her professionalism, attention to detail, and ability to navigate regulatory challenges make her an invaluable asset to any medical device company.
I highly recommend Golddy for her outstanding contributions and commitment to excellence.
I have worked with Golddy as part of a team, in a start-up organization, when we were trying to navigate our way towards scale-up and commercialization.
Golddy was instrumental in setting up the compass so we could establish direction and the tools required to reach destination.
Her knowledge, experience and effective analytical skills helped shape the strategy for a successful outcome.
I am grateful to have had the opportunity to work for Golddy at Profound Medical.
Golddy is a true leader who uplifts individuals and identifies their true potential.
She recruited me after I approached her through LinkedIn, offering me a chance to grow and learn under her guidance.
In addition to being a supportive mentor, Golddy is very well-versed in the field of complex regulatory filings, showcasing her expertise and knowledge in the industry.
Golddy's mentorship has been instrumental in my professional development.
She is a leader who genuinely cares about providing opportunities and support, even to complete strangers.
Her ability to inspire and guide others is truly commendable.
I worked closely with Golddy during the Sonalleve acquisition due diligence process.
Her ability to quickly grasp complex products and confidently navigate the intricacies of the regulatory landscape was truly impressive.
She possesses exceptional communication skills, articulating complex issues with remarkable clarity to both internal and external stakeholders.
She is a person of integrity and high ethical standards.
I enjoyed working with her, and I would recommend her as a highly competent Quality & Regulatory professional.
I worked with Golddy from 2005 to 2007 while she served as the Quality Manager on my team at XLTEK (now Natus). Peers in our organization expressed skepticism at my hiring decision, commenting, "Why are you hiring Golddy? She's such a strong Quality professional; she'll replace you someday!" My response was simple, "That's precisely why I chose to hire her!".
Golddy proved to be a dedicated and innovative team member, consistently seeking ways to enhance and refine our Quality Management System. Her strengths included creativity, curiosity, open-mindedness, and a strong focus on achieving goals.
When I left XLTEK in 2007 to pursue a different chapter in my career, I trusted Golddy was going to be more than capable of taking on my position. Since then, I have observed her successes and admire her incredible growth.
She has evolved into a highly regarded MedTech QA/RA/Clinical expert, demonstrating mastery through hard work and dedication. I highly recommend her services!
Working alongside Goldy was an invaluable learning experience. Her profound understanding of the industry, honed through years of experience in major corporations, combined with her ability to navigate the unique challenges of a startup environment, was truly remarkable.
She possesses a rare talent for seeing the broader strategic landscape, providing clarity and direction even in the most complex situations.
Beyond her expertise, she has a gift for recognizing and nurturing the potential in others, empowering them to understand their own value and contributions.
I wholeheartedly recommend her to any organization seeking strategic insight and impactful leadership.