Principal Regulatory Consultant (1099)
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Job Location:
Monthly Salary:
Experience Required:
Posted on:
8 hours ago
Vacancies:
1 Vacancy
Job Summary
This is a remote position.
Position Summary
MB&A is seeking a hands-on Principal Regulatory Consultant who combines recent real-world regulatory submission experience with practical Quality Engineering execution. This role is designed for consultants who actively prepare and submit filings engage directly with regulatory bodies and remain involved in hands-on quality activitiesnot purely advisory leadership.
Key Responsibilities
- Lead and personally execute global regulatory strategies for Class IIIII medical devices biologics and combination products.
- Prepare author and submit regulatory filings including 510(k) PMA IDE Technical Files Clinical Evaluation Reports and Q-subs with direct involvement.
- Drive EU MDR and FDA compliance activities with hands-on execution not oversight alone.
- Serve as primary liaison with FDA Notified Bodies and other health authorities including direct preparation of responses to findings (e.g. FDA 483s).
- Perform hands-on Quality Engineering activities in support of regulatory objectives including CAPA risk management and QMS support.
- Maintain and support QMS infrastructure including establishment registration GUDID and compliance with 21 CFR 820/QMSR and ISO standards.
- Support audit and inspection activities through direct participation and execution.
- Develop regulatory and quality training materials and support cross-functional teams.
- Serve as PRRC under EU MDR where applicable.
Requirements
Minimum Qualifications
- 15 years of experience in Regulatory Affairs and Quality within the medical device or life sciences industry.
- Demonstrated hands-on regulatory submission experience within the last 5 years including direct preparation and submission of FDA and/or EU filings.
- Recent hands-on Quality Engineering experience within the last 5 years supporting QMS CAPA risk management or inspection readiness.
- Strong working knowledge of FDA regulations EU MDR ISO 13485 ISO 14971 and related global standards.
- Proven experience interfacing directly with FDA and Notified Bodies.
- Excellent technical writing and regulatory communication skills.
Certifications (Preferred)
- CQA RAPS or equivalent Regulatory/Quality certifications
- PMP (preferred)
- MDR and Complaint Handling Training
Benefits
Why Join MB&A as a Consultant
MB&A offers senior consultants the opportunity to work on meaningful high-impact regulatory engagements that require both strategic insight and hands-on execution. Our projects are curated to align with consultant expertise while delivering measurable regulatory and quality outcomes for our clients.
Required Skills:
Minimum Qualifications 15 years of experience in Regulatory Affairs and Quality within the medical device or life sciences industry. Demonstrated hands-on regulatory submission experience within the last 5 years including direct preparation and submission of FDA and/or EU filings. Recent hands-on Quality Engineering experience within the last 5 years supporting QMS CAPA risk management or inspection readiness. Strong working knowledge of FDA regulations EU MDR ISO 13485 ISO 14971 and related global standards. Proven experience interfacing directly with FDA and Notified Bodies. Excellent technical writing and regulatory communication skills. Certifications (Preferred) CQA RAPS or equivalent Regulatory/Quality certifications PMP (preferred) MDR and Complaint Handling Training
Required Education:
Bachelors or Masters Degree in Mechanical Engineering Biomedical Engineering Engineering Science or related discipline.
Company Industry
IT Services and IT Consulting
Key Skills
- Enterprise Software
- SAP Warehouse Management
- AWS
- Solution Architecture
- SAP EWM
- SAP Finance & Controlling
- SAP Supply Chain Management
- SAP S/4HANA
- Enterprise Sales
- Pre-sales
- Management Consulting
- Oracle
