Role OverviewThis mid-level Regulatory Affairs position is responsible for integrating regulatory knowledge throughout the product lifecycle and coordinating projects effectively. The role supports the Regulatory Affairs team by communicating regulatory strategies and preparing essential documentation for market authorizations.
What You Will Do
The position involves participating in multidisciplinary teams, communicating regulatory requirements effectively, obtaining and evaluating the regulatory impact of proposed design and manufacturing changes, and preparing and submitting applicable regulatory documentation.
Why It Might Be a Fit
The ideal candidate will have strong communication and technical writing skills, a basic understanding of product risk/benefit concepts, and working knowledge of US and International regulations applicable to market authorization for Vascular products.
Requirements
- Associate or Bachelor’s degree in science or engineering disciplines
- 2-5 years of experience in a medical device organization, preferably in regulatory affairs
- Previous US, Canadian, and EU submissions experience preferred
- RAC certification preferred
- Ability to apply business and Regulatory Affairs ethical standards; analytical and critical thinking skills
- Proficient in Microsoft Office Suite
Benefits
- Medical insurance
- Prescription drug insurance
- Dental insurance
- Vision insurance
- Flexible spending accounts
- 401(k) savings plan
- PTO
- Short- and long-term disability insurance
- Parental leave
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