Senior Regulatory Affairs Specialist

Job Title: Senior Regulatory Affairs Specialist
Type: Contract
Compensation: $80.00 - $89.00 per hour
Work Model: Remote – offsite
Hours: 8am – 5pm

Overview
Join a leading medical technology organization as a Senior Regulatory Affairs Specialist supporting a high-visibility regulatory change initiative. In this contract role, you'll leverage your expertise in medical device regulations, labeling, and global documentation requirements to help drive compliance efforts in a collaborative, fast-paced environment.

Responsibilities

• Support for the Regulatory Actions associated with a Legal Manufacturer address change.
• Participate in Project Shift meetings and provide progress updates.
• Execute tasks related to the project efficiently and accurately.

Requirements

• Bachelor's Degree in a related field or 4+ years in the medical device industry.
• Familiarity with medical device labelling (IFUs, Product Labels, Patient Information Leaflets, Operative Techniques, etc) (2+).
• Familiarity with FDA Documentation and EU Technical Documentation (2+).
• Necessary soft skills: Attention to detail, organization, time management.
• Nice to Have:
  • Experience in regulatory assessments for changes to medical devices (2+).
  • Experience with CE marking requirements (2+).
  • Experience with the regulatory review of advertising and promotional materials (2+).

System One, and its subsidiaries including Joulé and Mountain Ltd., are leaders in delivering outsourced services and workforce solutions across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.

System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.