Employer Industry: Medical Devices

Why consider this job opportunity:
- Salary up to $131,000
- Annual bonus opportunities available
- Comprehensive medical, dental, and vision insurance
- Flexible work environment with the ability to work remotely from anywhere in the United States
- Opportunities for professional development, including tuition reimbursement and wellness programs
- Supportive company culture focused on helping surgeons treat their patients better

What to Expect (Job Responsibilities):
- Develop regulatory strategies and implementation plans for new products in the U.S., EU, and Canada
- Prepare and submit FDA, Notified Body, and Health Canada submissions for product approvals
- Advise Product Development Teams on regulatory requirements and documentation needed for submissions
- Review and approve design control documentation and engineering change requests for compliance
- Maintain positive relationships with regulatory agency personnel and provide ongoing support for marketed products

What is Required (Qualifications):
- Minimum of 5 years of relevant experience in regulatory affairs, preferably in the life sciences industry
- Bachelor's degree required; engineering or science discipline preferred
- Experience with orthopedic medical devices is preferred
- Proficiency in regulatory submissions and knowledge of IEC standards preferred
- Ability to communicate effectively both verbally and in writing

How to Stand Out (Preferred Qualifications):
- Advanced degree in a relevant field
- Regulatory Affairs Certification (RAC)
- Experience in authoring and submitting medical device registrations
- Familiarity with product labeling and advertising for medical devices
- Working knowledge of IEC 60601-1, IEC 62304, and EU RoHS/REACH

#MedicalDevices #RegulatoryAffairs #RemoteWork #CareerOpportunity #CompetitiveBenefits

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