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Staff Augmentation

Overview

Overview

The biggest challenge for the Medical Device industry is finding qualified talent in Regulatory functions. To keep pace in an accelerating global Regulatory environment and hit critical milestones, it requires the device manufacturers are accurately staffed with experienced and focused Regulatory experts. This is where Freyr supports the industry with staff augmentation services and 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 your team, quickly and easily.

Freyr can support the organization's Regulatory Medical Device staffing needs starting from the associate level to all the way through the senior level, covering essentially all key skill set or expertise required 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 Staff Augmentation Consulting span across several Regulatory functionalities in Medical Devices; a few sample skill sets are outlined below:

Freyr Regulatory Contract Staffing Expertise
(Representative List of Skill Sets)


Regulatory Affairs

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


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
  • linical Compliance Auditors (GCP)


Medical Writers

  • CER Specialists
  • PER Specialist
  • PMSR/PSUR/SSCP Specialists
  • Medical Reviewer
  • Clinical Trial Monitoring Specialist
  • Clinical Compliance Specialist
  • Literature Specialist
  • Clinical Project Manager
  • Toxicologists
  • Biostatistician


Labeling

  • Device Labeling Specialist
  • Device Labeling Reviewer
  • Labeling QC Specialist


PMS Specialists

  • Complaint Investigators
  • CAPA Specialist
  • CAPA Auditors
  • MDR Reporting Specialists
  • Recall Managers
  • Field Action Specialists
  • QPPV
  • PMS Study Specialist/Manager


Others

  • EU MDR Specialist
  • IVDR Specialist
  • 510(k) Specialist
  • De-Novo Specialist
  • PMA Specialist
  • Device History File Specialist
 
Freyr Expertise and Advantages
Expertise

Freyr Expertise

  • 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 zone and office coverage
Advantages

Freyr Advantages

  • Solutions tailor made to meet client’s Regulatory needs
  • Combination of quality project delivery with optimized cost providing overall value addition to Regulatory operations
  • Adaptable ramp up and down scenarios to manage client’s evolving Regulatory requirements
  • Efficient resource management during projects to ensure the quality