Regulatory Affairs Specialist

Stryker is hiring a Regulatory Affairs Specialist. This position is Hybrid/Onsite, supporting our Endoscopy Division in Tempe, Arizona.

What You Will Do

As a Regulatory Affairs Specialist, you will also ensure regulatory compliance through the maintenance of regulatory documentation and support review by FDA, Notified Bodies and other regulatory bodies.

• Identifies information sources and resources for local, regional, and global regulations
• Collects, organizes, and maintains files on local, regional, and global regulatory intelligence and other related information
• Monitors the regulatory environment (specific regulations, guidance and other relevant information by product types, geography, etc.)
• Provides information used to evaluate proposed products for regulatory classification and jurisdiction
• Research requirements (local, national, international), applicable guidance and standards and options for regulatory submissions, approval pathways, and compliance activities
• Assists in the development of regulatory procedures and SOPs
• Collects and organizes information on requirements for regulatory, quality, preclinical, and clinical data to meet applicable regulations
• Organizes materials from preclinical and clinical studies for review and assists in the review process
• Compiles and organizes materials for pre-submission reports and communications
• Assists in the preparation of dossiers and pre-submission and submission packages for regulatory agencies
• Tracks the status of applications under regulatory review and provides updates to the regulatory team
• Maintains logs of communication and outcomes with regulators and other relevant internal or external stakeholders
• Assists in the scheduling of meetings with internal stakeholders and regulators and develops and organizes materials for these meetings
  
  

Required

What you need

• Bachelor’s degree in engineering or science or related
• 0 – 2 years related work experience in an FDA or regulated industry required
  
  

Preferred

• 1+ years medical device or regulatory experience
• Knowledge of FDA and international medical device regulations and standards (CFR, MDR, QSR, ISO 13485, MDSAP, etc.)
• Ability to understand and explain detailed regulatory requirements among different countries and comply with constantly changing regulatory requirements
  
  

Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.