Medical Device Staff Augmentation Consulting

Freyr's medical device staff augmentation consulting provides expert Regulatory talent in a consultative and contract capacity to fill your resourcing needs. From the associate to the senior levels, we offer a wide range of key skills and expertise required in the Regulatory space. Whether you require short-term consulting or dedicated resource allocation, we have the flexibility to support your staffing needs.

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Medical Device Staff Augmentation Consulting – Overview

The biggest challenge for the medical device industry is finding qualified talent in Regulatory functions. Keeping pace in an accelerating global Regulatory environment and hitting critical milestones requires device manufacturers to be accurately staffed with experienced and focused Regulatory experts. This is where Freyr supports the industry with staff augmentation services and medical device staff augmentation consulting by providing Regulatory talent in a consultative and contract medical device staffing capacity, to fill broad or unique resourcing needs and augment teams quickly and easily.

Freyr can support your organization’s Regulatory medical device staffing needs, starting from the associate level to all the way through the senior level, essentially covering all key skillsets or expertise required in the Regulatory space. Our Regulatory medical device staffing experiences range from an individual associate-level resource to an expert Regulatory strategist, with extensive experience in multiple device categories and Regulatory topics. The services are flexible and could be a staff augmentation consulting or dedicated resource allocation.

Freyr’s Regulatory staff augmentation services or medical device staff augmentation consulting spans across several Regulatory functionalities. A few key skillsets are outlined below:

Freyr Regulatory Contract Staffing Expertise
(A Representative List of Skillsets)


Regulatory Affairs
  • Compilation Specialists
  • Regulatory Strategists – Country and Product-specific
  • Regulatory Specialists
  • Submission Specialists
  • International Regulatory Affairs Specialists
  • Publishing Specialists
  • Data Quality Assessment Specialists

Medical Device QMS Compliance Specialists (ISO 13485:2016, QSR, MDSAP)

Compliance and Validation

  • Vendor and Supplier Auditors
  • Internal Auditors
  • QMS Specialists
  • Trainers
  • Validation Consultants
  • Certified Lead Auditors
  • Clinical Compliance Auditors

Medical Writers
  • CER Specialists
  • PER Specialists
  • PMSR/PSUR/SSCP Specialists
  • Medical Reviewers
  • Clinical Trial Monitoring Specialists
  • Clinical Compliance Specialists
  • Literature Specialists
  • Clinical Project Managers
  • Toxicologists
  • Biostatisticians

Labeling
  • Device Labeling Specialists
  • Device Labeling Reviewers
  • Labeling QC Specialists

Post-market Surveillance (PMS)
  • Complaint Investigators
  • CAPA Specialists
  • CAPA Auditors
  • MDR Reporting Specialists
  • Recall Managers
  • Field Action Specialists
  • QPPV
  • PMS Study Specialists/Managers

Others
  • EU MDR Specialists
  • IVDR Specialists
  • 510(k) Specialists
  • De Novo Specialists
  • PMA Specialists
  • Device History File Specialists

Medical Device Staff Augmentation Consulting

  • Associate to expert-level resources covering major product categories and services areas.
  • Support in terms of onshore, nearshore and offshore model for resource placement.
  • 24X7 time zone coverage model to support multiple time zones and offices.
  • Tailored solutions to meet the customer’s Regulatory needs.
  • Combination of quality project delivery with optimized cost, which provides overall value addition to Regulatory operations.
  • Adaptable ramp-up and down scenarios to manage the customer’s evolving Regulatory requirements.
  • Efficient resource management during projects to ensure the quality.