Job Description
JOB DESCRIPTION
Job Title: Sr Consultant, Digital Health Compliance
Classification: Full Time
Location: Remote
Travel: Yes
Company Summary:
MEDIcept is an international medical device, IVD, combination product and biotechnology compliance consulting firm. For 25 years, our unique consulting practice has assisted thousands of companies of all sizes with cost- effective Regulatory, Quality, and Clinical services.
Please see www.medicept.com for more information.
Position Summary:
The Sr Consultant, Digital Health Compliance is a hands-on role supporting the Quality department. Must be a self-starter and a multi-tasker, as this position will work on multiple exciting client projects in tandem, specializing in Software as a Medical Device (SaMD), Software in a Medical Device (SiMD), AI/ML integration, and cybersecurity engagements.
Essential Duties and Responsibilities:
Successfully develop and manage Quality Management Systems to meet FDA QSR, ISO 13485, EU MDR, MDSAP, and other applicable regulatory requirements.
Conduct / lead / assist clients with internal, supplier, ISO 13485, CE Mark, MDSAP audits and FDA inspections.
Perform recidivist certification and due diligence audits.
Compliance strategy development, including enforcement action responses and/or corrective action plans (483s, warning letters, etc.), recall strategies.
Supplier Quality Management activities, including supplier audits and corrective action process (SCAR).
Deliver customized client training and education programs.
Corrective action strategy and development.
Preparation for FDA inspections and registrar or Notified Body assessments.
Identify client processes that may require improvement, correction, or additional contracted resources.
Successfully plan, manage, execute, and close turnkey projects within budget, and on time.
Develop strong relationships with clients, providing timely and accurate communications.
Deliver customized client training and education programs on Quality Management Systems and other industry topics.
Potentially serves client adjunct quality staffing (Interim Quality Professional)
Travel to customer sites as and when needed, up to 25% at a time.
Skills and Qualifications:
Bachelor’s degree in engineering, Regulatory and Compliance Management, Quality Engineering, or in a closely related / equivalent field.
Minimum ten (10) years of experience in software engineering, cybersecurity and risk management within medical device or digital health.
In-depth knowledge of 21 CFR 820, ISO 13485, IEC 62304, ISO 14971 and FDA pre/post-market cybersecurity guidance.
Understanding of software-based risk management, IoT ecosystem, security connectivity, and SBOM requirements.
Excellent communication (oral, written and verbal) and time management skills required.
Must be detail-oriented, thorough, and organized.
Excellent interpersonal skills with a customer service focus.
Ability to manage multiple projects simultaneously.
Must be self-motivated, able to work both independently and with a team.
Direct experience in AI/ML security and/or software-driven combination products a plus.
Cybersecurity0specific professional certification a plus.
Experience contributing to regulatory submission success for high-complexity software products a plus.
Please note the following:
Must be legally authorized to work in the U.S.
We are not currently sponsoring work visas.
Relocation is not available for this position as it is a remote role
We are an Equal Employment Opportunity employer. Drug free workplace.
We are following all state guidelines relative to safety precautions.
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