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