Medline
What to Expect (Job Responsibilities)
Plan and execute global regulatory activities to obtain and maintain regulatory approvals for medical devices
Determine requirements for product submissions and regulatory filings in assigned markets
Communicate regulatory requirements to internal and external stakeholders and recommend strategies
Review documentation and provide feedback to ensure compliance with applicable regulations
Collaborate with teams to maintain regulatory filings and respond to inquiries from regulators
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 ability to perform within it
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 product labeling and claims
Ability to act as a regulatory resource and subject matter expert within a team setting
Strong problem-solving skills and ability to collaborate effectively with diverse teams
Benefits
Salary up to $115,440 annually
Bonus and incentive eligible position
Comprehensive benefits package including health insurance, life and disability coverage, and 401(k) contributions
Opportunities for continuing education and professional development
Chance to work in a diverse and inclusive environment that values career growth
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 to obtain and maintain regulatory approvals for medical devices
Determine requirements for product submissions and regulatory filings in assigned markets
Communicate regulatory requirements to internal and external stakeholders and recommend strategies
Review documentation and provide feedback to ensure compliance with applicable regulations
Collaborate with teams to maintain regulatory filings and respond to inquiries from regulators
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 ability to perform within it
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 product labeling and claims
Ability to act as a regulatory resource and subject matter expert within a team setting
Strong problem-solving skills and ability to collaborate effectively with diverse teams
Benefits
Salary up to $115,440 annually
Bonus and incentive eligible position
Comprehensive benefits package including health insurance, life and disability coverage, and 401(k) contributions
Opportunities for continuing education and professional development
Chance to work in a diverse and inclusive environment that values career growth
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.
#J-18808-Ljbffr