Medline
Overview
Employer Industry: Medical Device Manufacturing Why consider this opportunity
Salary up to $115,440.00 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 professional development Supportive work environment that values diversity and inclusion Chance to work within a growing, global organization Responsibilities
Plan and execute global regulatory activities for obtaining and maintaining regulatory approvals Communicate regulatory requirements to internal and external stakeholders and recommend strategies Review documentation to ensure compliance with applicable regulatory standards Maintain regulatory filings by collaborating with various teams and addressing inquiries from regulators 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 discipline Minimum of 2 years of experience in medical device regulatory affairs or quality assurance Understanding of the current regulatory environment and ability to perform effectively within it Applied knowledge of FDA regulations and guidelines Ability to evaluate information for compliance with standards, laws, and regulations Preferred Qualifications
Experience in preparing regulatory submissions for medical devices Familiarity with international regulatory requirements Strong problem-solving skills and ability to act as a regulatory resource Excellent written and verbal communication skills Willingness to travel up to 5% #MedicalDevices #RegulatoryAffairs #CareerGrowth #CompetitivePay #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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Employer Industry: Medical Device Manufacturing Why consider this opportunity
Salary up to $115,440.00 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 professional development Supportive work environment that values diversity and inclusion Chance to work within a growing, global organization Responsibilities
Plan and execute global regulatory activities for obtaining and maintaining regulatory approvals Communicate regulatory requirements to internal and external stakeholders and recommend strategies Review documentation to ensure compliance with applicable regulatory standards Maintain regulatory filings by collaborating with various teams and addressing inquiries from regulators 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 discipline Minimum of 2 years of experience in medical device regulatory affairs or quality assurance Understanding of the current regulatory environment and ability to perform effectively within it Applied knowledge of FDA regulations and guidelines Ability to evaluate information for compliance with standards, laws, and regulations Preferred Qualifications
Experience in preparing regulatory submissions for medical devices Familiarity with international regulatory requirements Strong problem-solving skills and ability to act as a regulatory resource Excellent written and verbal communication skills Willingness to travel up to 5% #MedicalDevices #RegulatoryAffairs #CareerGrowth #CompetitivePay #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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