Role: Regulatory Affairs Consultant

Type: Remote, Part-Time (Approximately 20 hours/week)

Compensation: Based on experience

Must have: Regulatory Affairs candidate with hands-on experience managing 510(k) submissions for wheelchairs (both powered and non-powered).

Responsibilities

• Oversee the development and submission of 510(k) filings for wheelchair devices.
• Ensure compliance with FDA regulations specific to powered and non-powered wheelchairs.
• Collaborate with product development teams to compile technical files and documentation.
• Offer strategic advice to navigate regulatory challenges during the submission process.
• Respond to FDA inquiries and support the client through the review process.
• Requirements:
• Proven track record of successful 510(k) submissions for wheelchair devices.
• In-depth knowledge of FDA regulatory pathways for Class II medical devices.
• Familiarity with powered and non-powered wheelchair technologies.
• Strong analytical and organizational skills.
• Effective communication skills and ability to work remotely on a part-time schedule.
• Remark
• Reg Affairs Consultant candidate that has 510k experience with multiple wheelchairs (both powered and non-powered)