Manager, Fraud Risk & Compliance Operations
WEX
Regulatory Affairs Specialist
Stryker
full-time
Posted on:
Location Type: Hybrid
Location: Fremont • California, Utah • 🇺🇸 United States
Visit company websiteSalary
💰 $69,100 - $139,600 per year
Job Level
Mid-LevelSenior
About the role
- Support the Neurovascular product portfolio by assessing design, manufacturing, and labeling changes to ensure regulatory compliance throughout the product lifecycle.
- Advise cross-functional teams on regulatory pathways and requirements for changes to marketed devices in the US, EU, and Canada.
- Develop and update regulatory strategies in response to evolving regulations and product modifications.
- Evaluate regulatory environments and anticipate potential obstacles, proposing proactive solutions.
- Assess preclinical, clinical, and manufacturing changes to determine appropriate regulatory filing strategies or alternatives.
- Prepare and submit regulatory submissions (electronic and paper) in accordance with applicable guidelines and monitor review progress.
- Ensure alignment of clinical and nonclinical data with regulatory requirements to support product claims.
- Communicate effectively with regulatory authorities during submission development and review processes.
Requirements
- A bachelor’s degree (B.S or B.A) required; preferably in Engineering, Science or equivalent focus.
- Familiarity with FDA-regulated or other highly compliant industries, with a solid understanding of regulatory standards and practices.
- Exposure to Medical Device Regulatory Affairs or Engineering through coursework, internships, or project-based experience.
- RAC certification or Advanced Degree (Masters in Regulatory Affairs).
- Possesses a solid understanding of the product development process and design control principles, with prior experience working with U.S. Class II and Class III medical devices.
- Demonstrates strong analytical and writing skills, effective organizational abilities, and advanced proficiency in Microsoft Office Suite, particularly Excel.
Benefits
- Salary plus bonus eligible
- Health insurance
- Retirement plans
- Paid time off
- Flexible work arrangements
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory complianceregulatory strategiesregulatory submissionsclinical data alignmentdesign control principlesproduct development processregulatory filing strategiespreclinical assessmentmanufacturing changes assessmentlabeling changes assessment
Soft skills
analytical skillswriting skillsorganizational abilitiescommunication skills
Certifications
RAC certificationMasters in Regulatory Affairs
