r/MedicalDevices

Cold messaging on LinkedIn

If you are currently in the medical device or pharma sales field - what would a message from an entry-level candidate seeking a job in med device or pharma sales look like to impress you and prompt a response?

Would asking how you got into the field and being curious/avoiding talking about the job be the way to go? Or would it be better to flat out ask if you get a referral bonus?

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u/Expensive_Time_5912 — 4 hours ago

Thoughts on Route 92?

I currently work for a big 3 neurovascular company, and have been approached by Route 92 for a role. I’m familiar with their product line (aspiration catheter), but worried about selling just that.

The money is far greater than what I’m making now, around $100k a year more (250->350)

I’m going into a fresh territory with 0 sales so far

Would this opportunity be worth leaving my company where I have seniority and stability?

TIA

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u/Yallah_Habibi — 5 hours ago

Are medical device companies quietly exploiting the AI regulatory blind spot — and are we heading toward a wave of recalls because of it?

Genuine question for anyone working in regulatory affairs, medical devices, or compliance.

I come from market research and data analytics, so I think a lot about how decisions get made, and where the gaps between intention and execution show up.

Here’s the pattern I keep coming back to:

AI is being pushed hard across industries for efficiency and speed. Regulatory frameworks for AI-enabled medical devices are still being written. Health Canada, FDA, and EU regulators are all moving at different speeds and not always in sync.

And quietly, a lot of companies are eliminating senior regulatory affairs professionals from their org charts. Replacing them with legal teams, AI tools, or just not replacing them at all.

On paper that looks like cost optimization. But I wonder if something else is happening.

Here’s the sequence I keep seeing:

Senior RA professionals get asked to train offshore or international teams, junior staff in lower cost markets, to handle regulatory documentation, submission prep, and compliance monitoring. The knowledge transfer happens. The offshore team is up and running. And then the senior positions get eliminated.

It’s not unique to regulatory affairs. But in a field where judgment matters as much as process knowledge, it’s a particularly dangerous move. You can transfer the workflow. You can’t transfer 20 years of reading between the lines of a Health Canada guidance document, or knowing when a submission is technically compliant but likely to trigger a follow-up.

Senior RA people are expensive. Their value is invisible until something goes wrong. If you remove them during a period of regulatory ambiguity when the frameworks are still loose and enforcement is inconsistent. You create a window. Lower compliance friction. Faster time to market. Higher short term revenue.

And sales-driven leadership knows this.

The risk is real though. AI models drift. Post-market surveillance without experienced oversight misses signals early. Offshore teams trained on yesterday’s frameworks are navigating today’s moving targets without the institutional knowledge to know what’s changed and why. And when the regulatory frameworks do catch up, and they will. The gap between what was sold and what was actually validated is going to be hard to hide.

Recalls are expensive. Enforcement actions are public. Brand damage in healthcare takes years to recover from.

So my questions for people actually inside this space:

Is this pattern real or am I reading too much into it? Are companies knowingly taking this risk for short term revenue?

Are you seeing the offshore training and eliminate model play out in your organization or industry?

And, do you think we’re heading toward a wave of recalls driven by AI augmentation, cost cutting, and the regulatory blind spot it’s all creating?

Would genuinely love to hear from people closer to this than I am.

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u/Majestic_Turn3879 — 1 day ago

Stryker Canada

I have applied to stryker 4 times in hope that I will get in somehow. The last job I applied to was a distribution associate job in a warehouse. But unfortunately I got rejected from there too. I just wanna ask why? A person who has a bachelor degree can’t even get a warehouse job at Stryker??

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u/kakarot-gokuu — 20 hours ago

Gallop interview

Does anyone have tips for the gallop interview at Stryker?! I have a 3rd interview this week for an associate in sports medicine!! I have met with 3 employees- a rep, a general branch manager, and a on-site specialist and each of them told me this is the make or break round for Stryker!!

What was y'all's experience with this round?

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u/ava19992002 — 1 day ago

Worried about getting banned from facilities

I support accounts post-sale, something like a clinical specialist and key account manager. Big account got new products from us, I’ve been in on invitation to help support cases for a couple weeks.I want to come on-site now months later and support new physicians that are using the product.

I’ve been dropping by before the case starts, introducing myself as the educator, and asking the nurses if they would appreciate my support. It’s gone really well so far, the nurses love having me there to assist and the docs generally appreciate it as well. If I’m credentialed, I’m known as a resource, do you think I should be concerned about doing this?

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u/MrNattyyy — 1 day ago

Drafting CE certification - MDR

Hi all!

Just wanted to ask for some guidelines and resources to draft everything required for CE certification documents.

So far, this are the details:

- All our products are WET.

- We're a small team (around 5 people).

- I will be drafting the documents, then taking a revelant course in auditing (the goal is to be able to rely on our internal regulatory team in the long run), perfecting the draft, then send it to our consultant who will review the documents once drafted and will identify the gaps and guide us towards corrections.

- However, unlike ISO 13485 which has loads of material and practical guides and templates out there to draft the documents, I'm very out of depth with the drafting for CE.

Where I’m struggling is finding practical, structured guidance on how to actually draft the documentation.

What are the resources (besides MDR) that provide a guideline of what should be included in each section/document? I would appreciate books that can be used as reference as well. Are the MDCG enough to cover everything, or should they be supplemented with other materials?

The ideal would be something like Juuso's Developing an ISO 13485, but I don't seem to find anything close and the books I've found explain things superficially.

Also, for both CE and ISO 13485, which other ISOs should we take into account(e.g. ISO 14971, IEC 62366, etc)? (I've got a list of a bunch, but it's hard to determine what's required from what's extra and nice to have, it's our first time, it's so much it's overwhelming!)

Thank you so much in advance.

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u/leen_02 — 6 hours ago

I took the wrong job :-(

I had a few offers on the table.

Ended up choosing one that wasn't the highest paying - but seemed like a good fit.

Very disappointed in my choice.

I've been there about a month and a half. Not long at all.

I'm starting to apply at other places.

Do I even need to put this on my Resume? How am I going to explain this little hiccup?

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u/Dizzy_Quiet — 2 days ago

What’s the future for med devices and where do I go from here?

I know, it’s the golden question.

I’m 6 months into my associate role at S+N and have been enjoying it for the most part. I’m still fairly new and still learning every day but this being my first job out of college, I know I want to stay in medical device in the long run, just not sure if I should choose to pivot from here in the future.

Right now, I’m essentially an associate skin sub rep, the state of skin subs is kind of hostile at the moment with all of the changes in CMS and corruption in the past. I’ve been curious about Intuitive as it seems robotics is the future. What do you guys think is the future for medical devices and what devices would be the best to represent/companies to work for in the future?

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u/BedroomConfident5448 — 14 hours ago

How does MRI work and what can I consider in making one?

Hello there! Its John. And im here for a question that needs to be answered.

Just for a backround check. Im an inventor seeking for advices and knowledge regarding specific topics to aid my goal in making my inventions into reality. I do AR glasses, Hoverboard, Physics theories and medical tech being. This.

Since im developing an MRI machine affordable for 3rd world countries and in theory can cut medical expenses for patients needing this in half. Also the patient itself can use it standing up or laying down.

Now for the question: How do MRI machines work and why do they cost so... much.

I know you guys will ask "why ask this" or " Didn't they teach this at school" Well indeed they did. But just down how it works, what I need is the DEEP knowledge knowing regarding how MRI's work.

All from, what to use and why so expensive.

If would really help for you guys to aid me in this journey of mine, to help others. Whether your a norm, Hobbyist or a professional. I guranteed your time won't be wasted.

Thank for aiding my idea!

From: John

To: r/MedicalDevices

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u/Vegetable_Gift_6438 — 2 days ago

Incoming sales rep - best way to begin learning anatomy before I start?

Graduating in May and beginning a career in medical sales in June (big ortho/sports med company). Any tips from current reps on how to start learning basic/important anatomy so I am not on level 0 going in. Thank you!

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u/EnvironmentNo7666 — 2 days ago

Possible Career Change?

I’ve been in medical sales for 7 years now - changed from hospital sales to aesthetic capital sales within the past year. I’m trying to figure out if I want to continue down this path or change industries completely. Side note: I was very successful in hospital sales, but hated the companies I worked for. Now in aesthetic capital sales (lasers) I had to start from the bottom and miss the feeling that I was helping others & making a difference (also went from high salary to decent commission, to low salary & very high commission)

What are some roles for anyone here who has left med sales and found success elsewhere?

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u/chipotletennisqueef — 18 hours ago

Stryker job reposted 4 times

There’s a Stryker job in my area on LinkedIn that’s been open for like 3 months and has been reported 4 times. It gets about 20-50 clicks per linked in. Is this normal? Is Stryker that picky on who they hire? I’m applying for a different role but this reposted role is for Injury prevention and this job gets reposted all the damn time.

Sage sales rep injury prevention

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u/SelectHost8743 — 3 days ago

FDA QMSR 2026 is closer than most teams think — here's what's actually changing and how to prepare

Been doing a lot of work recently around QMSR readiness and wanted to share some observations because I'm seeing a lot of confusion out there — even among experienced QA teams.

Quick background: FDA's Quality Management System Regulation (QMSR) takes effect February 2026 and aligns 21 CFR Part 820 with ISO 13485:2016. On paper it sounds like a simple harmonization. In practice it's a meaningful shift for a lot of US-based device manufacturers.

Here's what I think is actually changing that teams are underestimating:

**1. Design controls get more rigorous**

ISO 13485 has stricter requirements around design and development planning than the old Part 820. If your DHF was built purely to legacy FDA expectations, you likely have gaps — particularly around design review records, verification/validation traceability, and transfer documentation.

**2. Complaint handling and feedback loops**

QMSR pushes harder on post-market surveillance integration. Your complaint handling process needs to feed into a documented feedback loop that demonstrably influences your risk management file. A lot of QMS setups I've seen treat these as separate silos.

**3. Risk management is now truly end-to-end**

ISO 14971 compliance has to be woven throughout — not just a standalone risk file you pull out for audits. Auditors will be looking at whether risk outputs actually connect to design decisions, labeling, and post-market data.

**4. Supplier controls**

ISO 13485 supplier requirements are more prescriptive than legacy Part 820. Supplier evaluation, monitoring, and re-evaluation cadences need to be documented and defensible.

**What's actually helping teams prepare:**

- Gap assessment against ISO 13485:2016 clause by clause, not just at the section level

- Updating your internal audit checklist to reflect QMSR language, not just old Part 820 language

- Making sure your design history file has a clear traceability matrix from user needs all the way through V&V

- Getting your risk management file genuinely integrated with your post-market surveillance process before an auditor asks for the connection

The teams I've seen handle this best are the ones treating QMSR transition as a full QMS audit — not just a documentation update exercise.

Happy to answer questions if anyone is working through specific gaps. This stuff is genuinely complex and every device category has its own wrinkles.

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u/koka786 — 2 days ago

LinkedIn Announcement

I just started my first medical device sales job and was curious when it would be considered “safe” to announce on LinkedIn?

I won’t be finished with training and orientation until mid-July, but that seems way too long after my start date to announce.

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u/Feisty_Plenty_5930 — 4 days ago

Can I be a present parent and do med?

I currently work in tech sales (educational software) and have been given the opportunity to explore jobs in med device and pharma. Here’s the thing:

I’m a new mom. I’m planning on working and being a SAHM isn’t a question, so that will never change my mind. I like having a career and making money. Am I going to be out of my mind doing med? Currently exploring ortho upper extremities and spine. I don’t mind working long hours but I am worried I may lose out on time with my kid while she is young. I also plan on having one more in the next 2 years.

Another concern is money, I make decent money with what I’m doing but don’t love it, and I’m the kind of person that needs to be passionate about my job. (Pulled in 120k this year).

All opinions welcome.

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u/_cayote — 4 days ago

Trauma reps, what are some pros and cons of being in the trauma division?

Hey guys, i'm interviewing next week for a trauma associate position for Globus. I just turned 22 years old and have been a scrub tech for over a year. What are some of the pros and cons and what should I really debate myself about for taking the job (if I do get it). Work life balance, pay, etc.

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u/Guilty-Jicama-8379 — 4 days ago

Hahahahahhaahahh they are screening people out

Stryker I was over qualified for jobs for years and just now finally put that I am disabled instead of I don't want to answer and they fucking immediately called me!!! Fucking yuuuuck

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u/AdministrativeCoat19 — 5 days ago

2 job ortho sales role help

Have 2 jobs interviewing for, both big companies in ortho sales, both intro med device

One is clinical work for year then start making commission once you know how to cover cases on your own

Other is low base but right off the bat u get percentage of territory

The pay is pretty equal. In final round of clinical job but just started 2nd round with other one. How should I negotiate if I’d rather not have the clinical one and the other even tho I just started interview process w other.

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u/Agitated_Pie_3822 — 2 days ago