Employer Industry: Medical Devices

Why consider this job opportunity:
- Salary up to $133,200 per year
- Eligible for a $1,000 employee referral bonus
- Comprehensive benefits package including health, dental, and vision insurance, tuition assistance, and a 401(k) plan with employer match
- Opportunity for career advancement and growth within a leading medical device company
- Flexibility to telecommute from anywhere in the United States
- Engaging work environment focused on regulatory compliance for innovative medical technologies

What to Expect (Job Responsibilities):
- Develop regulatory strategies and prepare submissions for U.S., EU, and international markets for Class I, II, and III medical devices
- Assess the regulatory impact of changes to approved products and coordinate the implementation of regulatory strategies
- Prepare document packages for regulatory submissions and inspections in compliance with FDA Quality Systems Regulation
- Communicate with regulatory agencies and serve as a regulatory liaison throughout the product lifecycle
- Navigate and adhere to worldwide regulatory requirements and government standards for medical devices

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 or R&D Engineer in Regulatory Affairs/R&D Engineering
- Experience with MDD/MDR design dossiers, technical files, and Design History Files for Class I, II, and III medical devices
- Knowledge of 21 CFR regulations and international medical device regulations
- Experience with total product life-cycle regulatory activities, including pre-clinical, clinical, approval, and post-approval phases

How to Stand Out (Preferred Qualifications):
- Additional experience with Common Submission Dossier (CSDT), Device Master File (DMF), and Japan Shonin
- Familiarity with ISO standards related to medical devices, such as ISO 13485 and ISO 14971

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