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.
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!
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.
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
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
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.
Dr. Mark Mannebach, former VP of Global Regulatory Affairs & Quality Assurance at Charleston Laboratories joins us to share his insights on what it took to get to "the top".
Mark joins us today with over 30 years of pharma industry experience, the majority in Regulatory Affairs. Over the years, Mark has held a variety of influential leadership roles with organizations such as Pfizer, Medtronic, Mallincrodkt, Baxter, and Santen.
Mark shares with us his insights of how he developed a passion for the industry at large, took to an interest in Regulatory, what he looks for when building his Elite teams, and why it's a great career path for those interested in learning more about RA/QA.
Mindfulness....gone are the days where you have to be a hippie, sitting with your legs crossed and your palms up, to be "mindful".
Let's face it...we lead stressful lives. Project deadlines, short on staff, kids' ballgames, getting dinner on the table, and on and on.....and on.....
With all the hype these days around the positive effects of meditation, or being "mindful", and with stars like Oprah, Andersen Cooper, and the guys at Google raving about the benefits, we thought we'd tackle this topic and shed some light as to how it might be beneficial to you and your team.
Check out the RA/QA Today podcast episode with Diane Renz, licensed psychotherapist, neuroscience practical applications facilitator, Seminar speaker, and Founder/Director of the Center for Healthy Habits, Body, Brain, & Behavior.
Some of the highlights we cover:
-What exactly is this "Mindfulness" thing?
-What benefits can you expect?
-How do you practice mindfulness when it seems you don't have time for anything else?
For more on Diane and her program:
Jose is the VP of RA/QA at Ionetics out of San Francisco, CA. He joins us with a diverse background having held a variety of leadership roles with organizations such as Cardinal Health and GSK, but also having run his own successful consulting firm for 16+ years. He has vast experience across the drug development spectrum as a chemist by trade and as a Regulatory & Quality Executive. Jose holds his PhD in Chemistry from Ohio State University. Today, Jose shares his insights for those considering making the transition, and leap, into consulting. You might be surprised as to what you hear.
Today we roll out another RA/QA Today podcast episode featuring Ms. Gowri Sukumar who is the Director of CMC and Regulatory Affairs for Betacat Pharmaceuticals in Houston, TX.
Gowri has a breadth of experience spanning across R&D, CMC, and Regulatory Affairs. Simultaneously, she serves a reviewer for several Bioscience journals across the world.
The topic we covered is "How to set specification limits for impurities in active pharmaceutical ingredients (API)."
Some of the items we cover in the episode:
-The first step to setting these specifications
-The most important tool to setting this specification
-What is acceptable and what is not considered acceptable specifications
...and so much more
Take any sport (basketball (MJ), golf (Tiger), football (Payton Manning)....those guys don't go out on the court without significant preparation.
Same with interviews...to be successful and demonstrate your value to the propsective employer, you need to prep!
Today we roll out another brand new RA/QA Today podcast episode.
Joining us for this episode is Ms. Tracy Burns, the CEO at NEHRA (Northeast HR Association, an affiliate of SHRM), the largest HR Association in the Northeast with over 2,000 HR professionals as members.
Prior to this role, Tracy spent nearly 20 years working in Corporate HR, most recently as a VP of Human Resources at Harvard Management Company. She's the author of the book Before and After Resumes, How to Turn a Good One Into a Great One and serves as the Chair Elect on the Board of The New England Society of Association Executives.
During this episode we discuss the Female CHRO development program NEHRA has recently developed.
Some of the highlights covered:
-How this CHRO program is different from any other Women's leadership program
-The key components of the CHRO development program
-Ideal participants for the program and what you need to do to qualify
..and much more
Joining us today is the VP of People from Nevro, Ms. Divya Ghatak.
With over 20 years of HR experience, Divya is responsible for all aspects of Talent, Culture, Engagement, Learning & Development, Total Rewards, and People Operations on a global scale. Prior to joining Nevro in 2017, Divya helped successfully drive the HR function for a variety of companies including Good Data and Sysco Systems.
Simultaneously, Divya is also on the Board of a Not-for-Profit organization called Watermark which is committed to increasing the number of Women in leadership roles.
For those unfamiliar with Nevro, the company is a rapidly growing medical device organization headquartered in Redwood City, CA. The organization has its HF-10 Therapy which is an innovative, evidence-based modulation platform for the treatment of chronic pain. Nevro went IPO in 2014 and has since won several awards for its open, inclusive culture.
During this episode, Divya and I discuss the nuances that occur within an organization going through such rapid change and growth.
At Northeastern, Stephen Amato oversees the faculty and educational services program within each of these key functional areas. Prior to joining Northeastern, Steve built a decorated 25+ year career having held a variety of leadership roles within the healthcare and life sciences industries such as Director of Global Regulatory Affairs, Reimbursement & Distribution, Director of Market Access and Marketing.
During this episode we discuss the controversial topic of the value and benefits of pursuing a Masters degree in Regulatory Affairs.
Some of the main points covered:
-Why should one consider pursuing an advanced degree in Reg Affairs
-Benefits students are receiving post-graduation as a result of their advanced degree
-Job outlook and market demand for Reg Affairs professionals
-Emerging trends Steve is seeing in this space (forecast over next 5 years)
Rashida Najmi is the SVP of Global Quality, Regulatory & Pharmacovigilance at Piramal Enterprises. Piramal Pharma Solutions, where the majority of Rashida's time is spent, is the contract development and manufacturing arm of Piramal Enterprises with operations across North America, UK, and India.
Rashida has over 27 years of experience building world class Quality and Regulatory programs across the World. She was recognized as one of the 50 most influential Quality professionals by the World Quality Congress in 2015.
During this episode we discuss pitfalls to look out for when hiring Quality professionals and building out your best in class Quality function.
Major points discussed:
-What to look for in your ideal Quality leader
-Different profiles of Quality leaders & how to gauge them
-Methods for interviewing Quality leaders
-Identifying the right fit for your organization's Quality leadership
-Warnings when hiring your Top Quality leader
This week on the RA/QA Today podcast we roll out an episode with our guest Brian Ellis, the Talent Attraction Manager at Align Technology.
Align Technology is a medical device organization known for the production of its 3D scanners and clear aligners headquartered in San Jose, CA.
You may not be familiar with Align technology, I can bet you most likely heard of its major, clear teeth alignment product, Invisalign.
Brian has built a career over the last 11+ years helping organizations scale Talent Acquisition processes, build global talent pipelines, and increase employer brand awareness.
Some of the key components Brian covers during the podcast:
-What exactly is Talent Branding
-How to leverage Talent Branding
-Out of the box ideas to get your employer brand out there
This episode is with a gentleman who is no stranger to the show. Rob Packard, the Owner and Founder of Medical Device Academy joined us to discuss the Global impact of the new European MDR and IVDR changes.
The Medical Device Academy is a consultancy specializing in 510k submissions and helping medical device and/or drug device organizations with quality and regulatory requirements.
Some things Rob covers during the show:
-What companies need to focus on first regarding these changes
-Which organizations will feel the most impact
-Forecast of changes being made to Regulatory & Quality departments
-Rob's recommendation on notified bodies
..and much more
Ms Liz Ashraf joins us on an episode of RA/QA Today to share her story for how she got to the top seat. Advil...I'm sure it, or a version of it, is in your cupboard somehwere. Guess what? Liz was part of the core team who helped get Advil approved and onto the market! Currently, Liz is the VP of Reg Affairs at a company called MaxiNovel Pharmaceuticals, a China based biotech organization focused on the discovery of Oncology drugs in the areas of Targeted Therapy and Immuno Oncology. Listen in as Liz shares her story and insights for her industry colleagues.
Ms. Mira Leiwant, VP of Regulatory Affairs at BTG plc was our guest. She joined us to discuss her journey to the top of the pyramid and insights for others looking to do the same, or perhaps for those who are leading the function, but open to ideas for strengthening their team. Mira has held a variety of leadership roles over the last 15 years across Quality, Compliance, and Regulatory Affairs. Her robust Regulatory & Quality experience spans across the US, Canada, and EU.
A few insights Mira shares:
-How to extend yourself outside your comfort zone for growth
-Leadership's responsibility for driving culture
-How to gauge future performance of your team members
Mr. David Kern joins us as the Founder/Owner of K2 Regulatory, a premier consulting firm helping life sciences organizations develop key regulatory and quality strategies. Prior to founding K2 David was the Head of Regulatory Affairs and Illumina where he helped build out the company's global Regulatory Affairs team and was instrumental in gaining the company's first ever PMA approval in 2017.
David joins us with great insights on
-The biggest misconception organizations have about Regulatory Affairs
-Why it's so tough to hire innovative Regulatory leaders
-How to foster innovative/creative thinking amongst Regulatory teams
-What makes a great Regulatory leader
-Why companies often think RA teams are too conservative and what to do about it
..and much more