We are seeking a highly motivated Entry-Level Regulatory Affairs Specialist to support regulatory strategy and compliance activities. This role offers a unique opportunity to gain hands-on experience in regulatory submissions, FDA interactions, and product development within a collaborative and fast-paced environment.

Key Responsibilities:

• Assist in preparing and submitting regulatory documents (e.g., INDs, IDEs, 510(k)s, and other FDA submissions)
• Support the development and maintenance of regulatory strategies for product development
• Compile, review, and maintain regulatory documentation and technical files
• Monitor and interpret regulatory guidelines, policies, and changes
• Ensure compliance with applicable FDA and international regulatory requirements
• Coordinate with cross-functional teams including R&D, Clinical, and Quality Assurance
• Assist in preparing responses to regulatory agency inquiries
• Maintain regulatory databases and document management systems

Minimum Qualifications:

• Bachelor’s degree in Life Sciences, Pharmacy, Biomedical Engineering, or related field
• Strong interest in Regulatory Affairs and healthcare product development
• Excellent written and verbal communication skills
• Strong attention to detail and organizational skills
• Ability to manage multiple tasks and meet deadlines
• Proficiency in Microsoft Office (Word, Excel, PowerPoint)
• Prior internship or coursework in regulatory affairs is a plus

Preferred Skills:

• Basic understanding of FDA regulations and submission pathways
• Familiarity with GxP (GLP, GMP, GCP) guidelines
• Ability to work independently and in a team-oriented environment

What We Offer

• Hands-on training and mentorship from experienced regulatory professionals
• Exposure to real-world regulatory submissions and clinical programs
• Opportunity for career growth in regulatory affairs and clinical development
• Competitive salary and benefits package

Job Type: Full-time

Pay: $50,000.00 - $70,000.00 per year

Benefits

• Flexible schedule
• Paid time off
• Professional development assistance
• Tuition reimbursement

Education

• Master's (Required)

Experience

• Microsoft Office: 1 year (Required)
• FDA Regulations: 1 year (Preferred)

Ability to Relocate:

• Gaithersburg, MD 20879: Relocate before starting work (Required)

Work Location: In person