Regulatory and Quality Compliance Expert

2 Days ago • 4-7 Years • Legal

Job Summary

Job Description

The primary duties involve performing all work in compliance with company quality procedures and standards. This includes assessing reportability for global and regional events, drafting and submitting adverse event reports, and completing field action tasks. The role requires staying informed of global vigilance reporting and field action regulations, advising external stakeholders, and representing the vigilance and/or field action function on cross-functional project teams. Responsibilities also include drafting and owning departmental procedures, completing quality updates, and managing improvement projects to support continuous improvement within the organization. A Bachelor's degree in a related scientific field with a minimum of 7 years of experience, or a Master's with 6 years, or a PhD with 4 years of experience is required. Additionally, at least 7 years in regulatory affairs or a similar regulated industry, with a preference for the medical device/IVD industry, and 4 years of project leadership experience are necessary.
Must have:
  • Work in compliance with quality procedures
  • Assess reportability for events
  • Draft and submit adverse event reports
  • Stay informed of global regulations
  • Advise external stakeholders on investigations
  • Represent function on project teams
  • Communicate vigilance and field actions
  • Draft and own departmental procedures
  • Complete graphs/presentations for quality updates
  • Support continuous improvement
  • Manage improvement projects
  • Ability to work in cross-functional teams
  • Complete work in time-sensitive environment
  • Lead complex projects independently
  • Strategic thinking and risk mitigation
  • Strong project ownership and mentorship
  • Attention to detail and organizational skills
  • Excellent written and verbal communication
  • Work with international stakeholders
  • Knowledge of medical device regulations (FDA, MEDDEV, ISO)
Good to have:
  • Medical device/IVD industry experience
  • Ability to identify and communicate risks
Perks:
  • Domestic travel required: 5% of time
  • International travel required: 5% of time

Job Details

Description

Primary Duties
 
  1. Perform all work in compliance with company quality procedures and standards.
  2. Assess reportability for both global and regional events; draft initial, follow-up, and final reports; and submit appropriate forms for adverse event reporting.
  3. Draft Health Hazard Assessments, field action board meeting minutes and utilize customer requirements management software to complete field action tasks.
  4. Stay informed of global regulations related to vigilance reporting and field actions.
  5. Advise external stakeholders on investigation requirements for vigilance reporting and field actions.
  6. Represent the vigilance and/or field action function on complex, cross-functional project teams, and inform on regulatory risks.
  7. Clearly communicate aspects of vigilance and/or field actions to Vigilance Operations Team (VOT) management and external team management.
  8. Draft and own departmental procedures (SOPs and work instruction documents and associated templates).
  9. Complete graphs and/or presentations for regular quality updates.
  10. Support an environment of continuous improvement throughout the organization.
  11. Manage improvement project.
    1. Performs other duties as assigned.
    Supplemental Data:
    • Ability to work well within a cross-functional team environment.
    • Capable to complete work in a time-sensitive environment
    • Able to begin, lead and oversee complex projects independently.
      Training and Education:
      Minimum education and/or training requirements for this position (i.e., high school diploma, college degree, and/or certification).
      Bachelors in related scientific field (e.g. biology, chemistry, bioengineering) and minimum 7 years, or Masters with minimum 6 years experience, or PhD with minimum 4 years experience
       
       
      Experience:
      1. 7+ years in regulatory affairs or equivalent regulated industry employment position, medical device/IVD industry preferred
      2. 4+ years leading projects
       Knowledge, Skills, Abilities:
      Knowledge, special skills, and/or abilities required to perform the job functions (e.g., negotiation, technical writing, statistical evaluation).
      • Ability to think strategically, identify and mitigate regulatory risks and maintain regulatory compliant processes and procedures.
      • Must demonstrate strong project ownership skills and peer mentorship skills.
      • Personable and service oriented with attention to detail, excellent organizational and time management skills.
      • Excellent written and verbal communication skills, including justification for vigilance related decisions or processes.
        • Skill to work in an international company with international stakeholders.
        Comprehensive knowledge of regulations applicable to medical device/IVD industry (FDA 806 & 803, MEDDEV Vigilance, QMS requirements (QSR 820 and ISO 13485)). Must be able to interpret regulatory requirements, determine needs for maintaining compliance, and effectively communicate this information to stakeholders.
      • The ability to work closely with management to identify and communicate areas of technical, schedule, and budget risk.
      • Act as a subject matter expert during regulatory inspections and audits, as needed.

Work Conditions:

Working Conditions and Environment:
Ability to remain in stationary position, often standing, for prolonged periods.
 Ability to ascend/descend stairs, ladders, ramps, and the like.
Ability to wear PPE correctly most of the day.
 Ability to operate heavy machinery.
 Ability to adjust or move objects up to 50 pounds in all directions.
 Domestic travel required    __5__ % of time
 International travel required   __5__ % of time

 

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