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Senior Regulatory Affairs Specialist, Program Lead
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Job Description
- Req#: R-016721
Employer Industry: Healthcare Innovation and Medical Technology
Why consider this job opportunity:
- Salary up to $160,000 annually
- Eligible for an annual performance bonus based on individual and company performance
- Comprehensive benefits package including medical, dental, vision, life insurance, and more
- Opportunities for career advancement and involvement in innovative healthcare solutions
- Flexible telecommuting options available
- Generous time off benefits, including vacation and holiday pay
What to Expect (Job Responsibilities):
- Author regulatory submissions and support product development stages to achieve US and international regulatory approval goals
- Manage, prepare, and submit regulatory submissions required for device approvals and registrations
- Collaborate with international colleagues on regulatory approval efforts
- Conduct regulatory evaluations of changes to devices and generate necessary regulatory submissions
- Provide expert regulatory feedback on specifications, device testing, and risk management documentation
What is Required (Qualifications):
- Master's degree in Pharmacy Administration, Biomechanical Engineering, or a related field
- Minimum of 4 years of experience in regulatory affairs or a related occupation
- Proven expertise in regulatory submissions and device approvals
- Strong understanding of regulatory requirements and compliance
- Excellent communication and collaboration skills
How to Stand Out (Preferred Qualifications):
- Experience as a Senior Regulatory Affairs Specialist or in a similar program lead role
- Familiarity with international regulatory standards and processes
- Background in clinical research and evaluations
- Ability to simplify complex problems into manageable tasks
- Experience with quality system and technical file audits
#HealthcareInnovation #RegulatoryAffairs #MedicalTechnology #CareerOpportunity #Telecommute
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