Offer summary

Qualifications:

Experience managing 510(k) submissions, In-depth knowledge of FDA regulations, Familiarity with wheelchair technologies, Strong analytical and organizational skills.

Key responsabilities:

Oversee development and submission of 510(k) filings

Ensure compliance with FDA regulations

Collaborate with product development teams

Offer strategic advice for submission processes

Respond to FDA inquiries during review

Job description

Job Title: Regulatory Affairs Consultant

Job Location: Myrtle Point, OR 97458, USA

Job Location Type: Remote

Job Contract Type: Part-time

Job Seniority Level: Mid-Senior level

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)

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