Regulatory Affairs Specialist
- Employer
- Entegee
- Location
- Racine
- Salary
- Competitive
View more
- Industry
- Government and Public Services
- Role
- Other
- Job Type
- Long-Term
- Hours
- Full Time
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Requirements: Minimum of 3-5 years of experience in regulatory affairs within the medical device/biotech/pharma industry required Knowledge on FDA Medical Device Reporting, Adverse Event, Recall and Fields Safety Correction Action (FSCA). Must pass 4 panel drug test (no marijuana tested)
Additional Preferred Requirements:Working knowledge of FDA medical device regulation, guidance documents, international standards (ISO 13485, ISO 14971), CE Mark required, EU MDD/MDR (Medical Device Regulations 2017/745EUMDR) preferred Medical Device is preferred.
Job Description:
As a Regulatory Affairs Specialist you will focus on providing regulatory support for new product development projects and maintaining continued market access of our existing product portfolio. The ideal candidate will be energetic, possess a strong regulatory background and performs well independently and as part of a team.
Equal Opportunity Employer/Veterans/Disabled
To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to
The Company will consider qualified applicants with arrest and conviction records
Additional Preferred Requirements:
Job Description:
As a Regulatory Affairs Specialist you will focus on providing regulatory support for new product development projects and maintaining continued market access of our existing product portfolio. The ideal candidate will be energetic, possess a strong regulatory background and performs well independently and as part of a team.
Equal Opportunity Employer/Veterans/Disabled
To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to
The Company will consider qualified applicants with arrest and conviction records
You need to sign in or create an account to save a job.
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