Quality & Regulatory in MedTech – Interview with Pardeep Kaur

Quality & Regulatory in MedTech – Interview with Pardeep Kaur

Background: From IT in India to MedTech in Norway

• You have a pretty fascinating background – you studied computer applications/IT back in India and now you’re a Quality/Regulatory Manager in the Norwegian medtech scene. Can you walk us through that journey? How did you go from an IT degree in India to working with medical device regulations in Norway? (What prompted the move and career change?)

• What were the biggest challenges when you switched into the medical devices field? For example, was there a steep learning curve with all the medical and regulatory jargon?

• And conversely, do you think your IT background gives you any unique advantages in QARA? (Maybe in handling technical documentation or bringing a fresh perspective?)

Day-to-Day as a QARA Manager

• Let’s talk about what a QARA Manager actually does. What does a typical day or week look like for you as a Quality and Regulatory Affairs Manager? (For instance, are you reviewing a lot of documents, meeting with engineers, training colleagues, dealing with audits… all of the above?)

• It would be great if you could mention some of the tools or software you use regularly. Are there specific QMS (Quality Management System) tools, document control systems, or even simple spreadsheets that are part of your daily routine?

• We often hear that QA/RA folks are like the “internal police” in a company – some colleagues think you just spend days reading boring regulations and chasing them to follow rules (laughs). How true or untrue is that stereotype? How would you describe the role to someone who thinks it might be dry or overly bureaucratic?

• On that note, an article I read actually said quality and regulatory roles are among the most dynamic and diverse in a company. You have to know a bit of everything – the tech, the laws, writing skills, you name it. What parts of the QARA role do you find most challenging, and which parts are the most rewarding?

• (For example, is it challenging that the scope is so broad – one moment you’re deep in engineering specs, next moment you’re updating a regulatory policy? And rewarding perhaps when a product finally gets approved or when you prevent a big issue?)

First MedTech Role at Hy5Pro AS

• Let’s dive into your work experiences. Your first QARA role in Norway was at Hy5Pro AS, a startup developing a pretty cool product – a hydraulic prosthetic hand for amputees. What was it like stepping into Quality/Regulatory at a company making robotic hands?

• (Feel free to explain what Hy5Pro’s product was and your role there, e.g. implementing the quality system, getting certifications, etc.)

• Do you have any memorable anecdotes from Hy5Pro? Perhaps a big challenge you faced early on or a funny incident while working on the prosthetic hand project. For instance, a lot of startups at that stage are trying to get their first ISO 13485 certification or pass initial regulatory hurdles – any story around that?

• (e.g. “the day the auditors came for ISO certification” or a time something went wrong and how the team fixed it – anything that was a learning moment for you.)

Leading QARA at RemovAid AS

• After Hy5, you moved on to RemovAid AS, which is another fascinating company – they created a device for removing contraceptive implants (a small gadget to help doctors remove those under-the-skin birth control implants). And I believe you were Head of Quality Assurance & Regulatory Compliance there. What were your main responsibilities at RemovAid, and how did it differ from your previous role?

• RemovAid’s product is a Class IIa medical device and was CE-marked under the new EU Medical Device Regulation. That sounds like a huge regulatory achievement. Can you share a proud moment from your time at RemovAid? For example, leading the company to ISO 13485 quality certification, or getting that CE approval, or the first time the device was manufactured at scale.

• (We saw on LinkedIn you celebrated the first RemovAid device coming off a high-volume production line – feel free to tell that story!)

• On the flipside, any tough or funny moments while at RemovAid? Perhaps juggling multiple roles in a small startup, or an unexpected problem that popped up (like a quirky product test failure or a documentation marathon just before a deadline)?

• RemovAid is in women’s health tech. Did working on a product aimed at female healthcare bring any special perspective or motivation for you? (Given it’s about making contraceptive care easier – that’s quite impactful.)

Consulting Experience at LINK Medical

• Now, currently you’re working at LINK Medical as a Medical Device Manager in their Quality/Regulatory team. So you went from being in-house at startups to a consulting role where you support multiple companies. What has that transition been like? How is life as a consultant different from working within a single company?

• I imagine as a consultant you get to see a variety of projects – different devices, different teams – which can be exciting. Can you share any interesting experiences from your consulting work so far? Maybe an example of a cool project you helped on, or a common mistake you see companies making with QARA that you help fix, or even a humorous experience of jumping into a new company’s project mid-stream.

• Also, how do you manage your time and sanity when juggling multiple clients or projects? That sounds challenging – any personal tricks you’ve learned for staying organized when everyone needs your expertise at once? (laughs – “the consultant life”)*

Diversity and International Career Insights

• I’d like to touch on diversity and your international experience. You’re a woman in the medtech industry and you’ve built your career across two countries and cultures. Have you faced any unique challenges as a woman working in medical devices and QARA? And what about being an international professional – any cultural adjustments or advantages you’ve noticed working in Norway compared to India?

• The medtech industry, especially in leadership, still isn’t very diverse – I read that less than a quarter of executive roles in medtech are held by women. How do you feel about the state of diversity in our field? Are things improving, and have you seen progress during your career?

• What advice would you give to companies or teams to foster a more inclusive environment, especially in fields like quality and regulatory? (Since those teams often work with all departments, they can influence company culture too.)

Rapid-Fire Round

Host: Okay, Pardeep, to wrap up on a fun note, we have a rapid-fire round! I’ll ask you a series of quick questions and you answer with the first thing that comes to mind. Ready? (brief pause) Go!

• Question 1: What’s one thing about your job that most people would be surprised to learn?

• Question 2: What’s the coolest medical device or gadget you’ve worked on or seen so far?

• Question 3: Are you team coffee or tea? (What fuels your workdays?)

• Question 4: Is there a quality/regulatory jargon or acronym you think is funny or confusing (and what does it actually mean)?

• Question 5: If you weren’t in QARA, what alternate career could you see yourself in?

• Question 6: What’s one Norwegian word or phrase you’ve picked up that you love to use? (Bonus: translate it for us!)*

• Question 7: If your career journey were made into a movie title, what would it be? (Just for fun!)

(Guest gives rapid-fire answers with laughter and brief commentary.)

Advice and Closing

• Now, before we sign off, I want to circle back to a more reflective note. What advice or words of inspiration do you have for junior professionals, students, or even folks thinking of switching careers into Quality and Regulatory in medtech? For someone listening who says, “This sounds interesting but also a bit overwhelming,” how can they prepare and what should they expect?

• (For example, should they get familiar with certain regulations or take courses? Find a mentor? Be ready to continually learn? Share any practical tips.)

• And maybe equally important, what should they not be scared of? People might think “Oh, I’m not a science or law expert, can I do this?” – any encouragement to help them overcome that hesitation?

Podcast Interview Questions for Pardeep Kaur (Reg compliance manager Oslo University Hospital)

1. Welcome & Setup

1. Can you briefly introduce yourself and describe your current role as a Quality & Regulatory Affairs Manager?

2. Career Journey

1. How did you go from earning a Computer Applications/IT degree in India to a QARA career in Norway?

2. What motivated you to switch into medical device regulations, and what were the biggest initial challenges?

3. In what ways has your IT background helped you excel in QARA?

3. Day-to-Day Responsibilities

1. What does a typical day or week look like for you as a QARA Manager?

2. Which tools or software (QMS systems, document controls, etc.) do you rely on most?

3. Is it true that QA/RA professionals are the “internal police”? How would you describe the role to someone who thinks it’s all paperwork?

4. Which aspects of QARA do you find most challenging, and which are the most rewarding?

4. Hy5Pro AS Experience

1. What was it like implementing QARA at Hy5Pro, developing a hydraulic prosthetic hand?

2. Can you share a memorable “learning moment” or funny anecdote from your time there?

5. RemovAid AS Experience

1. At RemovAid, you led Quality & Regulatory for a Class IIa implant-removal device—what were your core responsibilities?

2. Describe a proud milestone (e.g., ISO 13485 certification or CE marking) and the story behind it.

3. Any unexpected or humorous challenges you overcame in that role?

4. How did working on a women’s health product impact you personally?

6. LINK Medical Consulting

1. How has transitioning to a consulting role at LINK Medical differed from in-house QARA positions?

2. What’s a standout project or recurring compliance issue you help clients solve?

3. How do you stay organized when juggling multiple clients and deadlines?

7. Diversity & International Insights

1. As a woman in medtech QARA, have you faced any unique challenges or opportunities?

2. What cultural adjustments did you experience moving from India to Norway?

3. How can medtech teams become more inclusive, especially in QA/RA?

8. Rapid-Fire Round
   (Answer quickly with the first thing that comes to mind.)

1. One surprise fact about your job?

2. Coolest device or gadget you’ve worked on or seen?

3. Favorite (or funniest) QARA acronym—what does it mean?

4. Alternate career you might have chosen?

5. Norwegian word or phrase you love—translate it for us!

6. If your career were a movie title, what would it be?

9. Closing Advice

1. What practical steps should students or career-changers take to break into QARA?

2. What misconceptions shouldn’t they be afraid of when considering this field?

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