Regulatory Affairs Specialist

Immediate need for a talented Regulatory Affairs Specialist. This is a 12+ months contract opportunity with long-term potential and is located in Cleveland, OH(Hybrid). Please review the job description below and contact me ASAP if you are interested.

Job ID:25-88086

Pay Range: $45 - $47/hour.  Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).

Key Responsibilities:

• Provide regulatory input throughout product development to ensure alignment with global regulatory requirements for target markets.
• Develop and execute regulatory strategies based on product testing needs, clinical data, intended claims, and market dependencies.
• Lead and contribute to the preparation and submission of regulatory documentation including:
• 510(k) submissions (FDA - USA)
• EU MDR Technical Files (Europe)
• Global submissions to authorities such as NMPA (China), TGA (Australia), and others.
• Evaluate product changes and determine the regulatory impact (e.g., new or revised licenses/registrations).
• Plan and execute timely submission of renewal registrations and maintenance of product licenses across countries.
• Review and approve advertising, labeling, and promotional materials for regulatory compliance.
• Research and organize technical and scientific information from diverse sources for use in submissions and internal documentation.
• Ensure pre- and post-market compliance with applicable regulatory requirements.
• Support regulatory inspections and audits as required.

Key Requirements and Technology Experience: 

• Key Skills; Regulatory Affair,  regulatory frameworks,  medical devices, regulatory submissions, 510(k), EU MDR) or FDA
• Bachelor’s degree from an accredited institution in Life Sciences, Engineering, Regulatory Affairs, Pharmacy, Biomedical Science, or a related field.
• Minimum 4 years of experience in Regulatory Affairs or within a highly regulated industry (medical devices preferred).
• Strong knowledge of global regulatory frameworks, including FDA, EU MDR, NMPA, and TGA.
• Proficient in technical writing, documentation, and submission processes.
• Strong communication skills (both written and verbal) in English.
• Skilled in MS Office applications (Word, Excel, PowerPoint, Outlook).
• Regulatory Affairs Certification (RAC) by RAPS is highly desirable.
• Prior experience with medical device submissions and registrations.
• Strong analytical and problem-solving skills.
• Demonstrated ability to manage projects, work cross-functionally, and meet deadlines.
• Self-motivated, organized, and committed to continuous learning.

Our client is a leading Electric logistics Industry and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration.

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