Let's Combinate - Drugs + Devices22 Loka 2025

210 - The 8 Roles You MUST Understand in Pharma & MedTech

I get a lot of questions from students and early-career professionals about what different industry roles actually mean: what does a Quality Engineer do? What’s Regulatory Affairs? How does R&D fit in?

In this video, I walk through eight of the most common roles you’ll find in pharma, medtech, biotech, and diagnostics companies. We’ll talk about what each team does, how they connect, and how to think about which one might fit your strengths and interests.

If you’re trying to figure out where you belong in industry, this one’s for you.

Please like, share, and subscribe if you find it helpful!

Timestamps

00:00 Introduction and Background

01:07 Overview of Industry Roles

02:43 Quality Assurance

06:14 Regulatory Affairs

08:22 Research & Development

09:46 Clinical Affairs

11:07 Manufacturing & Operations

12:09 Quality Control / Analytical Testing

14:05 Supply Chain & Procurement

15:13 Validation & Technical Services

16:39 Career Path Insights and Conclusion

Subhi Saadeh is a Quality Professional and host of Let's Combinate. With a background in Quality, Manufacturing Operations and R&D he's worked in Large Medical Device/Pharma organizations to support the development and launch of Hardware Devices, Disposable Devices, and Combination Products for Vaccines, Generics, and Biologics. Subhi serves currently as the International Committee Chair for the Combination Products Coalition(CPC) and as a member of ASTM Committee E55 and also served as a committee member on AAMI's Combination Products Committee.For questions, inquiries or suggestions please reach out at letscombinate.com or on the show's LinkedIn Page.

Tämä jakso on lisätty Podme-palveluun avoimen RSS-syötteen kautta eikä se ole Podmen omaa tuotantoa. Siksi jakso saattaa sisältää mainontaa.

Jaksot(245)

224 - ICH Q2 Explained: What Analytical Validation Really Requires

In this episode of Let’s Combinate, host Subhi Saadeh breaks down the ICH Q2 guideline with a practical focus on analytical procedure validation. The discussion covers key definitions, core validation...

28 Tammi 10min

223 - What’s Changing in ICH Q1 and What Isn’t: Understanding Stability Expectations

In this episode of Let’s Combinate: Drugs and Devices, host Subhi Saadeh breaks down the 2025 draft update to the ICH Q1 guideline and explains what has actually changed and what has stayed the same.I...

21 Tammi 9min

222 - How ICH Guidelines Are Organized: Understanding the Q, S, E, and M Series

In this episode of Let’s Combinate: Drugs + Devices, host Subhi Saadeh continues the Combinating with ICH series by breaking down how the International Council for Harmonisation (ICH) guidelines are o...

14 Tammi 12min

221 - What Is ICH and Why It Matters

In this episode of Let’s Combinate: Drugs + Devices, Subhi Saadeh kicks off a new series focused on the International Council for Harmonisation (ICH) and its impact on drug and drug–device combination...

7 Tammi 14min

220 - Managing Oneself, Reflections and a New Series on ICH

🚀 Stay ahead in combination products, pharma, and medical devices 👉 https://www.letscombinate.com🎙️ Listen to more expert discussions on regulations, drug delivery, and quality 👉 https://www.letsc...

31 Joulu 20258min

219 - FDA PreCheck and the Future of Inspections: PAI to Pre-Readiness

In this episode of Let’s Combinate: Drugs + Devices, host Subhi Saadeh is joined by Ben Locwin to break down what’s changing in FDA pre-approval and pre-license inspections—and why the “inspection sid...

24 Joulu 202525min

218 - ICH Q13: Continuous Manufacturing EXPLAINED (Batch vs. Continuous)

In this short episode of Let’s Combinate: Drugs + Devices, Subhi Saadeh breaks down ICH Q13 and what “continuous manufacturing” actually means. He compares batch vs. continuous, explains how a batch s...

17 Joulu 20259min

217 - 5 Fixable Problems Holding Back Drug–Device Programs

In this episode of Let's Combinate: Drugs + Devices, host Subhi Saadeh addresses five significant quality issues in the combination product space. This episode provides practical insights and strategi...

10 Joulu 202517min