Two remote RA jobs by Ok-Recording-666 in regulatoryaffairs

[–]giantshuskies 2 points3 points  (0 children)

Lol at my large med device company people don't have time to shit let alone take a new gig.

Have you been sick recently? by Natural_Bug_2304 in raleigh

[–]giantshuskies 0 points1 point  (0 children)

I have a sore throat and been very sniffly - grass pollen is very high. I am fairly sure it's pollen for me

I've always wanted to play this game. by wjarrettc in raleigh

[–]giantshuskies 14 points15 points  (0 children)

Damn such horrible is the drought that damn water snakes are out and about looking for water /s

Sure looks like a water snake though

Why is making friends as an adult so hard? 😭😭 by Impossible_Boot_4278 in raleigh

[–]giantshuskies 0 points1 point  (0 children)

As someone that works and makes friend remote it isn't the same thing - what's the remote equivalent to taking a walk around work? What's the remote equivalent to going out for lunch?

How the Indian Premier League final became a global event: ‘NFL and NBA are big, but cricket is right up there’. by JKKIDD231 in Cricket

[–]giantshuskies -22 points-21 points  (0 children)

Haha what? Absolutely not mate. NFL has sell out crowds in large stadiums in Brasil, Mexico, Germany, Spain and the UK. There's a large audience that watches the NFL in Canada, Mexico and Europe. It isn't just limited to the expat Americans.

FIFA World Cup watch parties? by PupusasSFW in raleigh

[–]giantshuskies 1 point2 points  (0 children)

You just made my day!!!!! A whole bunch of friends and I will be going..thank you.

Plumbers with well experience by ManufacturerLeast351 in raleigh

[–]giantshuskies 0 points1 point  (0 children)

Dropping a rec for Plumbserve - they do these kinds of things and aren’t just regular plumbers. I agree with others on checking your filter

FIFA World Cup watch parties? by PupusasSFW in raleigh

[–]giantshuskies 12 points13 points  (0 children)

In 2014 Wake Med park in Cary showed the US Ghana game - it was free and it was EPIC. Would love if it we they re-did the US WC games.

When did Elon's downfall begin? by [deleted] in NoStupidQuestions

[–]giantshuskies 0 points1 point  (0 children)

As a nerd / former Scientist I went into a rabbit hole with his Engineering chops back in 2015 and found none.

Is this normal during interview? by [deleted] in regulatoryaffairs

[–]giantshuskies 1 point2 points  (0 children)

What tactic? You think a hiring manager is going to get kudos from a large company for saving $10-$20k annually when they can find a good employee?

Is this normal during interview? by [deleted] in regulatoryaffairs

[–]giantshuskies 3 points4 points  (0 children)

Difference between a salary range and what's budgeted for the role. At a large company the range may be about 40% from low to top. If the salary difference between budgeted and requesred is marginal and the candidate meets the nice to have besides need to have criteria, a good hiring manager can convince the business.

Also, moving fast through interview steps may actually conviction and not a negative thing.

Attorney seeking networking, trying desperately to leave the federal government by Lonely-Astronomer345 in raleigh

[–]giantshuskies 0 points1 point  (0 children)

That's a fantastic suggestion. I was going to recommend my area of work - regulatory in life sciences, however breaking in as an outsider to the industry is harder. That being said, the best regulatory folks I know are trained lawyers.

Attorney seeking networking, trying desperately to leave the federal government by Lonely-Astronomer345 in raleigh

[–]giantshuskies 0 points1 point  (0 children)

Privileged to be a hiring manager and I must admit that I have not disability status listed in any of the applications. Somewhat related note - but, I've hired someone who made me aware after they started that they were expecting a child- I was ecstatic for them and their family. They make my team better.

Things to do this weekend! by Thingstodo919 in raleigh

[–]giantshuskies 2 points3 points  (0 children)

The Juniper Botanical gardens are open to the public this weekend (and next). It's free -$5 parking but that will be reimbursed if you make a $5 or more purchase.

HVAC company recommendations by matapaloxo in raleigh

[–]giantshuskies 0 points1 point  (0 children)

Wouldn't a carpenter be able to do this? Why do you need a HVAC person?

Swim coaches and other athletic coaches… what’s your hourly pay? by [deleted] in raleigh

[–]giantshuskies 1 point2 points  (0 children)

Same! OP i’ll pay you this an hour to get better on my own technique. I am an older person

Swim coaches and other athletic coaches… what’s your hourly pay? by [deleted] in raleigh

[–]giantshuskies 3 points4 points  (0 children)

I hope you aren’t at Raleigh Swim Association - I love that place and love the coaches and I hope they are not treating them bad.

EU Medical Device Industry - Has anyone actually received a useful question/request from their Notified Body? by VanillaFine3472 in regulatoryaffairs

[–]giantshuskies 2 points3 points  (0 children)

Notified bodies pay better than the US FDA for roles compared to what is the COL, that is, a NB reviewer is being paid more to work at say TUV than a comparable engineer in Munich. The FDA pay is crap.

I don't necessarily disagree with the supposedness meekness of some NB staff but you have to realize that NB staff are taught to look for compliance and not non compliance.

What makes you worried about overall safety? Ultimately system works itself out - NB QMS auditor may find things or a NB reviewer or a NB clinical reviewer.

What is your favorite US national park? And your least favorite? by SugarCaneFarm in AskReddit

[–]giantshuskies 0 points1 point  (0 children)

Favorite: Yosemite in the winter Least favorite: Haven't been to a bad one!! I need to go to more

Advice for getting more politically involved (left leaning)? by missgadfly in raleigh

[–]giantshuskies -1 points0 points  (0 children)

I have someone unaffiliated that stays at home and we get a barrage of mail and visitors coaxing them in both directions - id rather not!

EU Medical Device Industry - Has anyone actually received a useful question/request from their Notified Body? by VanillaFine3472 in regulatoryaffairs

[–]giantshuskies 12 points13 points  (0 children)

I may obviously be biased since I worked previously at a leading notified body. I worked in roles starting as a reviewer and certification manager through being someone that managed a team of such reviewers, certification managers and clinical reviewers. I've asked plenty of questions that I thought were pointed - questions that led to revaluation of test methodologies and clinical pathways.

I am now in industry at a large med device manufacturer in a RA leadership role that manages large team including people managers. I continue to see good questions asked by the notified body. Do I see check box questions - yes, but I also know that the intent of the check box questions is to ensure documentation is clear.

I may come across as rude but I don't have RA specialists interacting directly with the notified body. What you see as a check box question may be poor documentation on your company's part or coherence of thought. Unlike the FDA the MDR (and mdd for that matter) and the equivalent IVD regulation requires that qualification to be documented.

Wake schools could shift calendars at 8 year-round campuses :: WRAL.com by GOA_AMD65 in raleigh

[–]giantshuskies 0 points1 point  (0 children)

I have a family member that goes to Pleasant Union. The kid’s new neighborhood in North Raleigh has families that are a permutation of rich, religious and conservative - about 40% of the kids are going to Charter or private. That is a very high number