35 Folgen

Have you ever wondered what it takes to get to the top of the Regulatory or Quality leadership food chain?

Or, are you struggling with a specific piece of your business, and you are wondering how others might be tackling the same issue?

Better yet, what about tips, tricks, and strategies for building high performance teams?

I'm excited to introduce to you the industry's first ever peer to peer platform, the RA/QA Today podcast. We have been hard at work, behind the scenes, interviewing a variety of best in class leaders from across the industry all so that you can be better armed to drive your business and your career forward.

RA/QA Today Mitch Robbins

    • Wirtschaft

Have you ever wondered what it takes to get to the top of the Regulatory or Quality leadership food chain?

Or, are you struggling with a specific piece of your business, and you are wondering how others might be tackling the same issue?

Better yet, what about tips, tricks, and strategies for building high performance teams?

I'm excited to introduce to you the industry's first ever peer to peer platform, the RA/QA Today podcast. We have been hard at work, behind the scenes, interviewing a variety of best in class leaders from across the industry all so that you can be better armed to drive your business and your career forward.

    Deborah Hiner-Med-Tech Start Up Recruitment Strategies

    Deborah Hiner-Med-Tech Start Up Recruitment Strategies

    Deborah Hiner, President & CEO of Deborah Hiner Consulting, joins us today to discuss critical strategies Med-Tech, Digital Health, & Diagnostics organizations can implement when in very early phases of building out the team. When you need to run lean, but need the fuel (talent) to drive business, these are the recruiting strategies that will help.

    For over 15 years, Deborah has built a career in helping organizations, both billion dollar companies and young, aspiring startups, to scale by building high-performing teams.

    The majority of her experience is centered in the Life Sciences.
    At the heart of her efforts, are the principals of performance based hiring.

    Check out this episode to learn the vital recruitment strategies you can implement in your start-up Med-Tech business today.

    • 22 Min.
    Jess Burger-Elite Escalator Mini Series

    Jess Burger-Elite Escalator Mini Series

    Joining us on this episode is Ms. Jessica Burger, Sr. Global Clinical and Regulatory Compliance Specialist at CooperVision.

    If you are unfamiliar, Coopervision with headquarters in Pleasanton, CA, is one of the world’s leading manufacturers of soft contact lenses and other related products and services.

    Jessica started her career in the Life Sciences industry approximately 10 years ago as a Microbiology Technician and then as a Microbiologist. In 2013, she made the transition into Regulatory Affairs at Bausch & Lomb and has progressively moved her way up the ladder having held various roles including Specialist, Sr. Specialist, and now in her current Sr Compliance role.

    She holds her bachelors degree in Biology and her Masters in Business Administration.

    Some highlights from the show:
    -Risks/Milestones that helped Jessica get to where she is today and advice she’d have for others in a similar spot
    -Her opinion on the future of what Regulatory looks like
    -Why she thinks it’s so important to be a subject matter expert, what that means, and how you can do the same….


    …and so much more!

    • 21 Min.
    Monir El Azzouzi

    Monir El Azzouzi

    Monir El Azzouzi is the founder of Easy Medical Device. Easy Medical Device is a platform dedicated to informing the public about medical device standards and regulations across the world.

    Monir has a tenured background in the Medical Device space having started out as a Biomedical Engineer and taking on progressive levels of leadership in Regulatory Affairs and Quality with organization such as Johnson & Johnson, Bausch & Lomb, and B. Braun.

    He comes to RA QA Today to discuss a huge industry "hot button"...that of the current Notified Body situation in the EU.

    • 18 Min.
    Elias Ketchum-Global RA Director-Genentech-Elite Escalator

    Elias Ketchum-Global RA Director-Genentech-Elite Escalator

    Today we roll out another RA/QA Today podcast episode, but this one is different from any of the others released thus far.

    Mr. Eli Ketchum, Global Regulatory Director for Personalized Healthcare at Genentech was our first guest as a part of our Elite Escalator Mini-Series.

    We have decided to create a mini-series with Technical Professionals (RA/QA/Engineering, etc) guests who are considered to be "rising stars" in their functional area.

    They are knockin the cover off the ball, consistently finding ways to shine and "climb the ladder".

    Some highlights from our show with Eli:
    -How and why it's important to be comfortable with being uncomfortable
    -Keys to his success to-date and how you can implement the same strategies
    -Keys to staying motivated and passionate

    ..and so much more

    • 23 Min.
    RAQA - Michelle Lott-Lean RA QA-Private Equity in the Life Sciences

    RAQA - Michelle Lott-Lean RA QA-Private Equity in the Life Sciences

    Michelle Lott is the Founder of Lean RA QA, an organization that provides organizations across the life sciences with regulatory strategy, regulatory submissions, quality systems compliance, due diligence, technical support services, and grief counseling! As we all know, working with regulators is tough stuff.

    Michelle also serves on the FDA Device Good Manufacturing Practices Advisory Committee.

    During this episode, Michelle discusses her insights as it relates to Private Equity and Venture Capital in the Life Sciences.

    Some of the highlights we cover:
    -How the rapidly changing Regulatory environment is impacting investments in the Life Sciences
    -What type of Regulatory information you can gleam even before a detailed design or prototype
    -Factors to indicate whether a company will have a successful exit
    -Trends in the M&A space within the Life Sciences

    Michelle and Lean RA QA can be found at leanraqa.com

    • 19 Min.
    Jon Speer-Greenlight Guru-True Quality

    Jon Speer-Greenlight Guru-True Quality

    Jon Speer, host of the Global Medical Device podcast and Founder/VP of RA/QA at Greenlight Guru, was kind enough to join us for this episode of RA/QA Today.

    Greenlight Guru is the world's leading QMS Software platform specifically for Medical Device organizations helping these companies get safer products to market faster.

    Jon has an educational background in Chemical Engineering and came on the show with over 20 years of Medical Device experience across multiple-functions such as Quality, Project Management, and Product Development.

    He's a regular content contributor to outlets such as QMed, Med City New, Med-Device Online and a variety of others.

    Listen in as Jon provides his perspective on what it means to drive "True Quality.

    • 25 Min.

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