Principal Specialist, Regulatory Affairs
Artex Risk Solutions
full-time
Posted on:
Location Type: Office
Location: Naples • Florida • United States
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Job Level
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
- 10+ 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 application
Soft Skills
problem-solvingeffective communicationteam collaborationrelationship buildingfeedback provisionsupport and guidanceclarity and consistency in documentationconsultationadaptabilityattention to detail
Certifications
Regulatory Affairs Certification (RAC)