ISG is recruiting for a local leading medical device company in Norfolk, Virginia, they are dedicated to improving healthcare outcomes through innovative products. As a company committed to quality and compliance, they are seeking a talented Regulatory Affairs Specialist to join the team and oversee the 510(k) submission process to the FDA.

Job Description:
As a Regulatory Affairs Specialist, you will play a critical role in ensuring compliance with FDA regulations for medical devices. You will be responsible for managing the entire 510(k) submission process, from initial preparation to final approval. This role requires a keen attention to detail, strong communication skills, and a thorough understanding of regulatory requirements in the medical device industry.

Key Responsibilities:

• Lead the preparation, compilation, and submission of 510(k) applications to the FDA for new and modified medical devices.
• Collaborate with cross-functional teams including R&D, Quality Assurance, and Manufacturing to gather necessary documentation and data for submissions.
• Conduct regulatory research to ensure compliance with current FDA regulations and guidelines.
• Review and analyze technical documentation to ensure accuracy and completeness.
• Coordinate communication with FDA reviewers and respond to inquiries or requests for additional information.
• Maintain regulatory files and documentation in accordance with company procedures and FDA requirements.
• Stay current on regulatory developments and communicate changes or updates to relevant stakeholders within the organization.

Qualifications:

• Demonstrated experience with preparing and submitting 510(k) applications to the FDA.
• Bachelor's degree in a related field (e.g., Regulatory Affairs, Life Sciences, Engineering).
• Experience in regulatory affairs within the medical device industry.
• Excellent written and verbal communication skills.
• Ability to work effectively in a fast-paced, deadline-driven environment.
• Detail-oriented with strong organizational skills.

Preferred Qualifications:

• Regulatory Affairs Certification (RAC) or equivalent.
• Experience with international regulatory submissions
• Familiarity with quality management systems (e.g., ISO 9001).
• Previous experience working with medical devices.

Benefits:

• Competitive salary (or hourly rate for contract position)
• Comprehensive benefits package including medical, dental, and vision coverage
• Retirement savings plan with employer match
• Paid time off and holidays

Job Types: Full-time, Contract

Pay: $47,771.73 - $57,531.55 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Experience level:

• 5 years

Schedule:

• Monday to Friday

Ability to Relocate:

• Norfolk, VA: Relocate before starting work (Required)

Work Location: In person