Artex Risk Solutions

Senior Specialist, Regulatory Affairs

Artex Risk Solutions

full-time

Posted on:

Location Type: Office

Location: Naples • Florida • United States

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Job Level

Senior

About the role

  • Develop U.S., EU and Canada regulatory strategy and implementation plans for the preparation and submission of new products and review any proposed changes for impact on regulatory strategy and status.
  • Evaluate the risk of proposed regulatory strategies and offer solutions, as applicable.
  • Advise and provide regulatory direction to assigned Product Development Team(s) on the regulatory requirements, documentation and testing needed for FDA, EU MDR & Health Canada regulatory submissions and registrations during the development of new devices, device modifications, and changes to existing products.
  • Prepare, write, and submit FDA, Notified Body and Health Canada submissions for new products and product changes as required in accordance with established time-lines and submission dates to ensure timely approvals while in compliance with regulations.
  • Partner with International Regulatory Affairs to provide regulatory support for new products and changes to existing products.
  • Provide business and product information to International Regulatory Affairs to enable development of strategies and communicate that information to assigned Product Development Team(s).
  • Review and approve design control documentation, engineering change requests for design, manufacturing and labeling changes, and customs requests to ensure compliance with global regulations.
  • Provide feedback and on-going support to Product Development Team(s) to resolve (potential) regulatory issues and questions from regulatory agencies.
  • Rigorously review regulatory documentation to ensure completeness, clarity, consistency, and conformance to regulations and guidelines.
  • Coordinate and consult with manager and/or other departments on the content and review of regulatory documentation.
  • Provide support to currently-marketed products as necessary. This includes: reviewing labeling; reviewing promotional material; reviewing product changes; preparing documentation for changes requiring government approval; and preparing submissions and reports for regulatory agencies as required by product status.
  • Interact with FDA, Notified Bodies and/or Health Canada on products at reviewer level.
  • Establish, develop and maintain positive relationships with regulatory agency personnel.
  • Maintain proficiency in applicable regulatory requirements.

Requirements

  • 5+ years relevant experience required preferably in a regulatory affairs role in the life science industry.
  • Bachelor’s degree required, engineering or science discipline preferred.
  • Advanced degree preferred.
  • Orthopedic medical device experience preferred.
  • Regulatory Affairs Certification (RAC) preferred.
  • Experience authoring and submitting medical device registrations/licenses/submissions applicable to regional area.
  • Experience reviewing product labeling and advertising/promotional material for medical devices.
  • Proficiency in the use of PC and programs, particularly Excel, Word (or equivalent if changed by the Company), QAD or similar inventory software.
  • Ability to define problems, collect data, establish facts, and draw valid conclusions.
  • Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
  • Ability to comprehend and apply mathematical principles to the degree required to perform the job based upon job requirements.
  • Ability to comprehend and apply language skills to the degree required to perform the job based upon the job requirements listed above.
  • Ability to verbally communicate ideas and issues effectively to other team members and management.
  • Ability to write and record data and information as required by procedures
Benefits
  • Medical, Dental and Vision Insurance
  • Company-Provided Life Insurance
  • Voluntary Life Insurance
  • Flexible Spending Account (FSA)
  • Supplemental Insurance Plans (Accident, Cancer, Hospital, Critical Illness)
  • Matching 401(k) Retirement Plan
  • Annual Bonus
  • Wellness Incentive Program
  • Free Onsite Medical Clinics
  • Free Onsite Lunch
  • Tuition Reimbursement Program
  • Trip of a Lifetime
  • Paid Parental Leave
  • Paid Time Off
  • Volunteer PTO
  • Employee Assistance Provider (EAP)
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
regulatory strategy developmentregulatory submissionsrisk evaluationdesign control documentationmedical device registrationslabeling reviewpromotional material reviewdata analysistechnical instruction interpretationmathematical principles application
Soft Skills
problem-solvingeffective communicationteam collaborationrelationship buildingfeedback provisionsupport provisionclarity in documentationorganizational skillsconsultationadaptability
Certifications
Regulatory Affairs Certification (RAC)