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Senior Regulatory Affairs Specialist (Remote - United States)
This job is now closed
Job Description
- Req#: R01126598
Employer Industry: Healthcare and Medical Devices
Why consider this job opportunity:
- Salary up to $170,500
- Opportunity for career advancement and growth within the organization
- Work remotely anywhere within the United States
- Comprehensive benefits package including Medical, Dental & Vision, and Retirement Benefits
- Chance to collaborate with innovative and diverse teams in the healthcare sector
- Engaging work environment focused on solving challenging healthcare problems
What to Expect (Job Responsibilities):
- Develop and execute regulatory strategies for new product market authorizations
- Manage complex decision-making among cross-functional stakeholders
- Participate in global business and functional strategic meetings representing regulatory affairs
- Submit regulatory documents and follow through on evaluations until authorization is obtained
- Review advertising and promotional materials to ensure compliance with regulatory claims
What is Required (Qualifications):
- Bachelor's Degree or higher AND seven (7) years of experience in Regulatory Affairs & Medical Device
OR
- High School Diploma/GED and eleven (11) years of experience in Regulatory Affairs & Medical Device
- Three (3) years of experience with electromechanical medical devices
- Three (3) years of experience with regulatory submissions including 510(k) and EU MDR submissions
- Proven experience in managing regulatory compliance throughout the product lifecycle
- Must be legally authorized to work in the country of employment without sponsorship for employment visa status
How to Stand Out (Preferred Qualifications):
- Bachelor's Degree or higher in electrical engineering, mechanical engineering, or software engineering/programming
- Advanced degree in Scientific, Engineering, or Regulatory/Quality
- Five (5) years of experience with electromechanical medical devices
- Experience with temperature management and negative pressure wound devices
- Three (3) years of experience supporting ISO 13485 and MDSAP audits
#Healthcare #RegulatoryAffairs #MedicalDevices #RemoteWork #CareerOpportunity #CompetitivePay
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