Regulatory Affairs Specialists

Job Description

We are actively seeking dedicated Regulatory Affairs Specialists to join our team in Atlanta. In this role, you will be instrumental in ensuring compliance with all applicable regulations related to our medical products. Your expertise will guide our approach to regulatory submissions and strategic compliance management.

Responsibilities

• Draft, review, and update regulatory submissions.
• Ensure timely compliance with all regulatory deadlines.
• Advise on regulations impacting product development and marketing.
• Analyze and interpret regulatory guidance and documents.
• Assist in regulatory audits and inspections.
• Participate in risk management and mitigation strategies.
• Coordinate with various departments to meet regulatory requirements.
• Maintain current knowledge of industry trends and regulatory changes.
• Support product recalls or adverse event reporting when necessary.

Requirements

Education

• Bachelor's degree in Biomedical Engineering or a life sciences field
• Relevant certifications in regulatory affairs are a plus

Experience

• 4-6 years of relevant regulatory experience.

Technical Skills

• FDA Regulations
• Project Management

Soft Skills

• Analytical Thinking
• Team Collaboration

Certifications

• Certified Regulatory Affairs Professional (CRAP)

Languages

• English: Fluent

Advantageous

• Proficiency in additional languages.: Ability to communicate effectively with international teams.
• Experience in clinical trials.: Knowledge of the regulatory aspects of conducting clinical trials.

Benefits

• Comprehensive health coverage including dental and vision
• 401(k) with employer match
• Flexible work schedule with remote options
• Attendance at industry conferences and workshops

Company Culture

• Continuous Improvement: We seek ways to improve every day, fostering a culture of ongoing learning.
• Employee Empowerment: We empower our employees with the tools and authority to make decisions.
• Integrity and Responsibility: We act with integrity in all interactions, holding ourselves accountable.