Job Description

Choose a job you love, and you will never have to work a day in your life. — Confucius

Regulatory Affairs Specialist

  • Job Tag: #LI-AR2
  • Posted: February 10,2023

SkyWater is partnering with a global medical device manufacturer who’s looking for an experienced Regulatory Affairs Specialist to join their team! This person will be responsible for 510(k) submissions, working directly with the FDA, maintaining regulatory filings, overseeing post-market surveillance and much more. Our client is an industry leader in providing safe, effective, and cost-friendly products to patients around the world. We’re looking for someone with a Bachelor’s Degree in Chemistry, Biology, or a related field, 2+ years of regulatory affairs experience and experience working with IVD products. Our client is offering a strong compensation package (base plus bonus potential), outstanding benefits (low costs for health coverage, HSA contributions, 401K + match plan, PTO, etc.) and a hybrid work schedule. If you’re looking for an exciting opportunity to join an industry leading company where you can make an impact, then please submit your resume today!


  • Prepare & submit 510(k) submissions.
  • Work directly with the FDA on regulatory filings.
  • Oversee post-market surveillance of products.
  • Stay up to date on regulatory industry changes.
  • Other duties or projects as assigned.

Desired Skills and Experience

  • Bachelor’s Degree in Chemistry, Biology, or a related field.
  • 2+ years of regulatory affairs experience or a similar combination of experience.
  • Experience with IVD products.
  • Strong communication skills (both verbal & written).

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