Medline
Overview
Why consider this job opportunity: Salary up to $115,440 annually Bonus and/or incentive eligibility Comprehensive benefits package, including health insurance, life and disability coverage, and 401(k) contributions Opportunities for continuing education and training Potential for career advancement within a growing worldwide organization Commitment to diversity and inclusion in the workplace Responsibilities
Plan and execute global regulatory activities for obtaining and maintaining regulatory approvals Communicate regulatory requirements to internal and external customers and recommend strategies Review documentation to ensure compliance with applicable regulatory requirements Complete and maintain regulatory filings by collaborating with various teams and addressing non-conformances Participate in the development and review of product labeling and claims Qualifications
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 operate within it Applied knowledge of FDA regulations and guidelines Ability to evaluate information to ensure compliance with standards, laws, and regulations Preferred Qualifications
Experience working with complex regulatory issues and providing feedback on documentation Strong problem-solving skills and ability to act as a regulatory resource and subject matter expert Additional Information
#MedicalDevices #RegulatoryAffairs #CareerGrowth #CompetitiveBenefits #DiversityAndInclusion We prioritize candidate privacy and champion equal-opportunity employment. Central to our mission is our partnership with companies that share this commitment. We aim to foster a fair, transparent, and secure hiring environment for all. If you encounter any employer not adhering to these principles, please bring it to our attention immediately. We are not the EOR (Employer of Record) for this position. Our role in this specific opportunity is to connect outstanding candidates with a top-tier employer.
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Why consider this job opportunity: Salary up to $115,440 annually Bonus and/or incentive eligibility Comprehensive benefits package, including health insurance, life and disability coverage, and 401(k) contributions Opportunities for continuing education and training Potential for career advancement within a growing worldwide organization Commitment to diversity and inclusion in the workplace Responsibilities
Plan and execute global regulatory activities for obtaining and maintaining regulatory approvals Communicate regulatory requirements to internal and external customers and recommend strategies Review documentation to ensure compliance with applicable regulatory requirements Complete and maintain regulatory filings by collaborating with various teams and addressing non-conformances Participate in the development and review of product labeling and claims Qualifications
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 operate within it Applied knowledge of FDA regulations and guidelines Ability to evaluate information to ensure compliance with standards, laws, and regulations Preferred Qualifications
Experience working with complex regulatory issues and providing feedback on documentation Strong problem-solving skills and ability to act as a regulatory resource and subject matter expert Additional Information
#MedicalDevices #RegulatoryAffairs #CareerGrowth #CompetitiveBenefits #DiversityAndInclusion We prioritize candidate privacy and champion equal-opportunity employment. Central to our mission is our partnership with companies that share this commitment. We aim to foster a fair, transparent, and secure hiring environment for all. If you encounter any employer not adhering to these principles, please bring it to our attention immediately. We are not the EOR (Employer of Record) for this position. Our role in this specific opportunity is to connect outstanding candidates with a top-tier employer.
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