Medline Industries
Regulatory Affairs Specialist
6 days agoWhat's your preference?
Job Description
- Req#: R2507960
Employer Industry: Medical Devices
Why consider this job opportunity:
- Salary up to $115,440 annually
- Eligible for bonuses and incentives based on performance
- Comprehensive benefits package including health insurance, life and disability coverage, and 401(k) contributions
- Opportunities for continuing education and training within a growing global organization
- Collaborative work environment with a focus on diversity and inclusion
- Travel requirement of up to 5% for the role
What to Expect (Job Responsibilities):
- Plan and execute global regulatory activities to obtain and maintain regulatory approvals
- Communicate regulatory requirements to internal and external customers and recommend strategies
- Review documentation to ensure compliance with applicable regulatory requirements
- Collaborate with internal and external groups to complete and maintain regulatory filings
- Participate in the development and review 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 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 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 preparing regulatory submissions for new devices and market launches
- Familiarity with post-market regulatory changes and requirements
- Strong problem-solving skills and ability to act as a subject matter expert in regulatory affairs
- Effective communication skills for presenting project objectives and collaborating with teams
#MedicalDevices #RegulatoryAffairs #CareerOpportunity #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."About the company
Notice
Talentify is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status.
Talentify provides reasonable accommodations to qualified applicants with disabilities, including disabled veterans. Request assistance at accessibility@talentify.io or 407-000-0000.
Federal law requires every new hire to complete Form I-9 and present proof of identity and U.S. work eligibility.
An Automated Employment Decision Tool (AEDT) will score your job-related skills and responses. Bias-audit & data-use details: www.talentify.io/bias-audit-report. NYC applicants may request an alternative process or accommodation at aedt@talentify.io or 407-000-0000.