Medical Device Senior Consultant

Synergy Bioscience is a start-up company providing pharmaceutical product R&D, Laboratory testing, and quality compliance consulting services.

We are looking for a medical device design control consultant for one of our clients located in the USA. The ideal candidate shall have experience with medical devices design control, Human Factors Engineering, and Biocompatibility experience.

Minimum of fifteen (15) years of experience as a Quality and/or Compliance professional working in the FDA, regulated industry (i.e. Medical Device, Pharmaceutical, Biotechnology, etc.) or as a Consultant. Masters or Doctorate level of education or equivalent experience preferred. Must be proficient in writing and presentations skills. The ability to travel both domestically and internationally is a major aspect of the role.

Lead Auditor, Subject Matter Expert, Coach and Trainer in a FDA regulated environment. Work solo or on teams providing strategic consultation and/or performing remediation following FDA Compliance Actions (FDA-483s and Warning Letters). Team Lead and/or Project Manager/Leader on large or complex projects with multiple work streams (includes the management of resources). Must have the ability to audit and assess Device Quality systems and/or Drug GMPs to ensure compliance with FDA requirements.

Experience in conducting, managing, and leading internal/external audits, which may include QSR and/or cGMP audits. Experience in the area of FDA Inspection Preparation, subject matter expert for FDA inspections, and developing responses to FDA-483 observations.

Experience as Subject Matter Expert (SME) in more than one of the following areas:

• Complaint Handling and Post Market Reporting
• Production & Process Controls (including Process Validation)
• Design Controls
• Risk Management
• CAPA
• Computer System Validation
• Purchasing & Supplier Controls
• Management Controls

In-depth knowledge and experience working with 21 CFR Parts 4, 820, 210/211, 803, 806, as well as ISO 13485, 14971 and related International Requirements.