Medline
Employer Industry: Medical Devices
Why consider this job opportunity:
Salary up to $115,440 annually
Bonus and/or incentive eligible
Comprehensive benefits package including health insurance, life and disability, and 401(k) contributions
Opportunities for continuing education and training
Chance to work with a growing worldwide organization dedicated to diversity and inclusion
Collaborative work environment with a focus on employee growth and development
What to Expect (Job Responsibilities):
Plan and execute global regulatory activities for product submissions and approvals Communicate regulatory requirements to internal and external stakeholders Review documentation to ensure compliance with regulatory standards Collaborate with teams to maintain regulatory filings and respond to inquiries from regulators Participate in the development and review of product labeling and claims What is Required (Qualifications):
B.A. or B.S. degree in life sciences, engineering, medical technology, regulatory science, or a related field 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 for compliance with standards, laws, and regulations How to Stand Out (Preferred Qualifications):
Experience working with international regulatory requirements Familiarity with quality management systems in the medical device industry Strong problem-solving skills and the ability to act as a subject matter expert Excellent communication skills, both written and verbal Willingness to travel up to 5% 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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Plan and execute global regulatory activities for product submissions and approvals Communicate regulatory requirements to internal and external stakeholders Review documentation to ensure compliance with regulatory standards Collaborate with teams to maintain regulatory filings and respond to inquiries from regulators Participate in the development and review of product labeling and claims What is Required (Qualifications):
B.A. or B.S. degree in life sciences, engineering, medical technology, regulatory science, or a related field 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 for compliance with standards, laws, and regulations How to Stand Out (Preferred Qualifications):
Experience working with international regulatory requirements Familiarity with quality management systems in the medical device industry Strong problem-solving skills and the ability to act as a subject matter expert Excellent communication skills, both written and verbal Willingness to travel up to 5% 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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