Medline
Employer Industry: Medical Device Manufacturing
Why consider this job 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 and inclusive work environment that values diversity and growth
What to Expect (Job Responsibilities):
Plan and execute global regulatory activities 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, recommending pathways and strategies Review documentation and provide feedback to ensure compliance with regulatory standards Participate in the development and substantiation of product labeling and claims What is Required (Qualifications):
B.A. or B.S. degree in a life science field, engineering, medical technology, regulatory science, or a related area Minimum of 2 years of experience in medical device regulatory affairs or quality assurance Understanding of the current regulatory environment and the ability to perform 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 in developing regulatory strategies for new devices and launch markets Familiarity with international regulatory requirements and processes Strong problem-solving skills and ability to act as a subject matter expert in regulatory affairs 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 obtaining and maintaining regulatory approvals Determine requirements for product submissions and regulatory filings in assigned markets Communicate regulatory requirements to internal and external customers, recommending pathways and strategies Review documentation and provide feedback to ensure compliance with regulatory standards Participate in the development and substantiation of product labeling and claims What is Required (Qualifications):
B.A. or B.S. degree in a life science field, engineering, medical technology, regulatory science, or a related area Minimum of 2 years of experience in medical device regulatory affairs or quality assurance Understanding of the current regulatory environment and the ability to perform 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 in developing regulatory strategies for new devices and launch markets Familiarity with international regulatory requirements and processes Strong problem-solving skills and ability to act as a subject matter expert in regulatory affairs 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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