Our Expertise.
Full time placements
The level of positions and talent we work range from mid-level individual contributors to Sr. Vice Presidents and our clients range in size from two person incubator startups to global Fortune 100 companies and everything in between. We have worked across most if not all technology platforms in the Medical Device and Diagnostic industries encompassing all FDA, EU and ROW regulatory classifications. From Design Assurance to Post Market Surveillance, BRC knows who to call and where to go for the talent you seek.
Consultants and Contractors
Not ready to hire full time yet? Then let us find you the right contract employee or consultant. Our many years of leadership roles with ASQ Medical Device Division, RAPS Boston Chapter and Academia combined with our proprietary recruitment network provides you access to SME’s here in the US and from across the globe. Among our talent partners are Clinical, Regulatory and Quality focused consulting firms, individual SME’s and former FDA, EU and ROW industry executives and regulators. Tailoring each contract according to a project’s scope, size, and budget, we secure the appropriate resources and talent to get your project done on time and within budget.
EU Certified Representative (EC Rep) / UK Responsible Person (UKRP)
Biomedical Resource Consultants has partnered with a certified European Authorized Representative (EC REP) / UK Responsible Person (UKRP) to bring our clients services that assist with the registration of Medical Devices, Diagnostic Devices, IVD’s and Cosmetics. Our new BRC partner is strategically located in one of the most convenient places in Europe in terms of regulations, costs and logistics: Spain. With additional offices in London (UK) and the US, we are well positioned to support our clients needs in the EC, the UK, the US and ROW.
Regulatory positions & talent
Regulatory Submissions - FDA 510(k), DeNovo, PMA, IDE, EU CE Mark per MDR, Health Canada, Asia Pacific & ROW
Regulatory Strategy
Regulatory Intelligence
Regulatory Compliance
Reimbursement
Device Classification
Adverse event reporting
483’s and Warning Letters
UDI
Establishment Registrations
Quality positions & talent
Quality Management Systems
ISO 13485, 21 CFR Part 820, MDD/MDR, IVDR and ROW regulations.
Due Diligence audits
Quality Engineering
Software Quality
Supplier Quality
Design Assurance
Quality Control / Testing / Inspections
Risk Management
Post Market Surveillance
Medical Device Single Audit Program (MDSAP)
Remediation, Recalls, Consent Decrees
Sterilization / Microbiology
Clinical positions & talent
Clinical trial design, management, reporting and closeout
Study design and protocol development
Clinical document creation and management
Clinical trial monitoring
First-in-human clinical trial design and management
Pre-trial site evaluation and qualification
Clinical database development, entry, processing, querying, maintenance and reporting
Training
IRBs, Ethics Committees and other agencies
Sample jobs & case studies
Examples of typical assignments include:
Manager, Director and VP level Quality; Regulatory and/or Clinical
Regulatory Specialists / Associates; Mid, Senior and Principal levels
Quality Engineers, Systems Specialist, Auditors; Mid, Senior and Principal levels
Clinical Specialists / Associates; Mid, Senior and Principal levels
Sterilization / Microbiological Specialists to Directors