Product Validation Consultant

Job Description

Job Title: Product Validation Consultant

Start Date: ASAP

Duration: 3 months + opportunity to extend

Logistics: Primarily onsite, could taper to hybrid later in project

Hours/week: 40 to start. Most likely for first 3 months. Depending on project needs and extension, could taper down to less than 40 hours

Additional Info:

Urgent need that arose this morning, tied to a 510(k) submission for the CardioSave Class II balloon pump, currently under an FDA consent decree.

Consultant will need to operate beyond a purely regulatory role — must bring deep product system validation expertise and the ability to determine the right amount of testing and documentation for submission readiness.

Focus is on evaluating the product objectively, identifying gaps, and ensuring the proper planning, processes, and validation execution are in place.

Travel expenses will be covered as needed to get someone to commit/relocate to be onsite in Wayne, NJ

No set budget or established pay scale — decision-making process still being defined.

JOB DESCRIPTION:

Overview:

We are seeking an experienced Product Validation Consultant to support an urgent 510(k) submission for a Class II cardiovascular medical device currently under an FDA consent decree. The consultant will provide deep product system validation expertise, ensuring the right amount of testing and documentation is completed to meet regulatory expectations and submission timelines.

Responsibilities:

Lead and execute product system validation activities for a Class II medical device in preparation for 510(k) submission.

Evaluate the current product objectively, identifying validation gaps and required testing.

Develop and implement validation plans, strategies, and processes to ensure compliance.

Collaborate with engineering, quality, and regulatory teams to align on requirements and testing priorities.

Provide guidance on appropriate testing levels, documentation, and readiness for submission.

Support preparation and review of all required validation and submission documentation.

Requirements:

Proven experience with product system validation for Class II medical devices.

Hands-on experience supporting FDA 510(k) submissions.

Strong knowledge of validation planning, requirements definition, and execution processes.

Ability to work both strategically (big picture) and tactically (“in the weeds” with technical details).

Excellent communication and documentation skills.

Able to work onsite in Wayne, NJ.

Collaborative engagement with engineering, regulatory, and quality teams.

Preference will be given to candidates with:

Experience with cardiovascular devices or other highly regulated medical devices is highly desire

Familiarity with operating under an FDA consent decree