Your quality and regulatory manager, without a full-time hire
I serve as your QA/RA manager, or work alongside the one you already have. I keep the quality system running, handle what comes up on the regulatory side, and make sure you're ready when the notified body or the FDA arrives.
Three situations where this works best
You need the role, but not a full-time employee. I take it on, part-time, with the same responsibility.
There is more work than one person can carry, or they want a senior person to think with. I work alongside them.
Audits, complaints, changes and reports don't stop after certification. I keep the system alive between audits.
You don't have a QA/RA manager yet
Your QA/RA manager needs a partner
You are certified, and the work keeps coming
A notified body audit or an FDA inspection is coming within the next year.
Your QA/RA person left, and nobody owns the quality system right now.
Your QA/RA manager is away for a while, on maternity leave or long reserve duty, and someone needs to cover the role.
Design changes and ECOs accumulate, and no one checks their regulatory impact.
Complaints, PMS reports, and CAPAs are waiting for someone to close them.
You are entering a new market, or a regulation you work under is changing.
You probably need this if one of these sounds familiar
One person who knows your system, quality and regulatory
Document control, CAPA, training records, internal audits and management review, done on time.
Technical documentation updates, change assessments and reporting to authorities.
PMS plans and reports, PSURs, trend reviews and incident reporting.
Preparation, answering the notified body's questions, and support on the audit days.
Fixed hours each month and a regular check-in, so nothing waits until the last minute.
When a hard question comes up, you call one person who already knows your system.
A quality system that runs
Regulatory work handled
PMS and vigilance
Ready for every audit
A regular rhythm
Someone to call
From a first call to a regular rhythm
You tell me about the device, the market and your timelines. I tell you what I'd do first.
When needed, I review your procedures, technical file or recent audit reports.
Scope, hours per month and how we'll work together. I work by the hour.
Fixed days or hours, a monthly check-in, and changes as your needs change.
A first call
A look at what you have
A clear proposal
Consistent pace of work
The company brought me on two days a week, ahead of its certification audit. I updated the quality management system, answered the notified body's questions, and guided the team throughout the audit, which ended in certification. Since then, I've continued with them as a partner for QA/RA: in additional notified body audits, technical file updates, and the ECO and CAPA changes that keep coming in.
A dental navigation company
It depends on where your company is. We agree on it in the proposal and adjust it as your needs change.
Mostly remotely. When something needs me on site, such as an audit, we plan it together.
Yes. Many companies start with one project and continue with ongoing support afterwards.
How many hours a month does it take?
Do you work on site or remotely?
Can we start with a single project?
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A 30-minute call. You tell me where you are, and I tell you what I'd do first and how much of my time it would take.