Regulatory Affairs Specialist

Overview

Why consider this job opportunity:

• Salary up to $115,440.00 annually
• Bonus and/or incentive eligible
• Comprehensive benefits package including health insurance, 401(k) contributions, and paid time off
• Opportunities for continuing education and training within a growing global organization
• Supportive and inclusive work environment that promotes diversity and career growth
• Potential for travel up to 5%

• Plan and execute global regulatory activities necessary for obtaining and maintaining regulatory approvals
• Determine requirements for product submissions and regulatory filings in assigned markets
• Communicate regulatory requirements to internal and external customers and recommend strategies
• Collaborate with teams to complete and maintain regulatory filings, addressing non-conformances and questions from regulators
• Participate in the development and review of product labeling and claims

• B.A. or B.S. degree in a life science field, engineering, medical technology, regulatory science, or related area
• Minimum of 2 years of experience in medical device regulatory affairs or quality assurance
• Understanding of the current regulatory environment and ability to perform within it
• Applied knowledge of FDA regulations and guidelines
• Ability to evaluate information for compliance with standards, laws, and regulations

• Experience with product submissions and regulatory strategies in a global context
• Familiarity with medical device labeling requirements and claims substantiation
• Strong problem-solving skills and ability to act as a regulatory subject matter expert

#MedicalDevices #RegulatoryAffairs #CareerGrowth #CompetitiveCompensation #DiversityAndInclusion

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