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Senior Regulatory Affairs Specialists
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Job Description
- Req#: R20125
Employer Industry: Medical Device Manufacturing
Why consider this job opportunity:
- Salary up to $133,200 per year
- Qualifies for a $1,000 employee referral bonus
- Comprehensive benefits including health, dental, vision insurance, and tuition assistance
- Opportunities for career advancement and growth within the organization
- Flexible telecommuting options available from anywhere in the United States
- Supportive work environment with a focus on employee well-being
What to Expect (Job Responsibilities):
- Develop regulatory strategies and prepare submissions for U.S., EU, and international markets for Class I, II, and III devices
- Support market expansion and product development teams by identifying regulatory requirements
- Prepare document packages for regulatory submissions and FDA inspections
- Communicate with regulatory agencies and serve as a liaison throughout the product lifecycle
- Navigate and ensure adherence to worldwide regulatory requirements and industry standards
What is Required (Qualifications):
- Master's degree in Regulatory Affairs, Biomedical Engineering, Chemistry, or a closely related field
- Minimum of two (2) years' experience as a Regulatory Affairs Specialist, R&D Engineer, or in a related occupation
- Experience must include two (2) years of progressive experience with MDD/MDR design dossiers and regulatory activities
- Familiarity with 21 CFR regulations and international medical device regulations
- Knowledge of Quality System Regulation (QSR) and ISO standards
How to Stand Out (Preferred Qualifications):
- Experience with Common Submission Dossier (CSDT) and Device Master File (DMF)
- Background in total product life-cycle regulatory activities, including clinical and post-approval phases
#MedicalDevices #RegulatoryAffairs #CareerOpportunity #Telecommuting #EmployeeBenefits
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