In this episode of The MedTech Talent Lab, Mitch Robbins sits down with Elena Mack, Chief Quality Officer at Sanisure, to discuss her career journey and insights into the world of quality and regulatory leadership in the medical device industry. With over 25 years of experience, Elena has held key executive roles at companies like Olympus, BD, and Teva Pharmaceuticals. Now, as part of Sanisher, she is leading the charge to build and maintain a world-class quality program for the bioprocessing and biomanufacturing sectors.

Elena shares her early career experiences, including her shift from medical technology to microbiology and how she got started at Wyeth in a regulatory compliance role. She reflects on pivotal moments in her career, including taking on a leadership role as a director at ACUPAC and the invaluable lessons she learned about leadership, delegation, and the importance of empowering her team.

Throughout the conversation, Elena also delves into the challenges of being a quality executive, emphasizing the responsibility of ensuring that quality is a shared value across all levels of an organization. She highlights the critical importance of having a robust quality system and talks about the ongoing efforts at Sanisher to move from ISO 9001 to ISO 13485, aiming to meet the highest standards of quality required by their customers.

With her unique perspective on quality as a critical but often underappreciated function in the industry, Elena offers valuable insights into the role of quality professionals and how they can drive real impact within their organizations.

Key Takeaways:

• The importance of leadership by example and empowering teams.
• The challenges and rewards of stepping into executive roles and delegating responsibilities.
• The need for robust quality systems in bioprocessing and biomanufacturing, especially in meeting regulatory standards.
• Elena’s personal connection to quality through her experiences with her son’s health challenges.

Links:

• Elena on Linkedin https://www.linkedin.com/in/elena-mack-bb57855/
• Sanisure Website www.sanisure.com

In this episode of The Med-Tech Talent Lab podcast, host Mitch Robbins interviews Mary McNamara-Cullinane, Vice President of Regulatory Affairs at ClearPoint Neuro, about her 25+ year journey in the medical device regulatory space.

Key Highlights:

• Mary shares her background as the youngest of eight children and how her early work ethic shaped her career path
• Learn how Mary transitioned from research to regulatory affairs through roles at Brigham and Women's, CRBARD, and a 17-year consulting career
• Discover what makes an outstanding regulatory professional in today's environment
• Understand the challenges regulatory executives face when balancing company goals with regulatory requirements

Practical Takeaways:

• Why proactive research and understanding the "why" behind regulations separates exceptional regulatory professionals
• The importance of managing leadership expectations around FDA timelines
• Why submitting complete FDA submissions is more efficient than rushing deficient ones
• Thoughts on remote work effectiveness in regulatory roles

Mary also discusses ClearPoint Neuro's exciting work with gene therapy companies and their recent partnership with PTC Therapeutics to address rare diseases in children.

Whether you're a regulatory professional looking to advance your career or an executive trying to better understand the regulatory landscape, this conversation offers valuable insights from a seasoned industry leader.

Mary McNamara-Cullinane on LinkedIn: https://www.linkedin.com/in/marymcnamaracullinane/

ClearPoint Neuro on the web:

https://www.clearpointneuro.com/

In this episode of The MedTech Talent Lab, host Mitch Robbins sits down with Carolyn Twomey, Global VP of Medical Affairs and Research at Iramax Corporation. Carolyn’s career path is nothing short of remarkable—from starting as an OR nurse and cardiac cath lab director to leading global clinical services and now shaping medical affairs strategy in the medical device industry.

She shares her personal and professional transformation, including:

How an early passion for music unexpectedly led her to nursing.

The pivotal career shifts that took her from clinical practice to corporate leadership.

The emotional impact of battling cancer while simultaneously losing her sister to the disease—and how it shaped her leadership and perspective.

The critical role medical affairs plays in bridging science, clinical practice, and commercial success in MedTech.

Lessons on resilience, adaptability, and building a meaningful career in the industry.

Why You Should Listen:

🎧 Gain insights into career growth strategies in MedTech and medical affairs.

🎧 Learn how to leverage clinical experience for leadership roles in the industry.

🎧 Hear an inspiring story of overcoming adversity and thriving in healthcare leadership.

🎧 Understand the evolving role of medical affairs in innovation and patient impact.

Don't miss this engaging and deeply personal conversation with a leader who’s making a difference in MedTech!