Regulatory Affairs Specialist - Lower Extremities/Biologics

Regulatory Affairs Specialist – Lower Extremities/Biologics

Memphis, TN

Stryker is looking for a Regulatory Affairs Specialist to join our Trauma & Extremities Biologics team. In this role, you will help bring innovative soft tissue and biologic medical technologies to market while ensuring compliance with global regulatory requirements. You will work independently and cross-functionally to drive strategic regulatory initiatives, prepare submissions, and interact with regulatory agencies and internal partners.

Work Flexibility: Hybrid

Candidates must reside within a commutable distance to Memphis, TN, and be available to work onsite two days per week.

What You’ll Do

• Prepare regulatory submissions and pre-submission materials for global health authorities
• Research global regulatory requirements, standards, and approval pathways to support product development and compliance
• Support development and maintenance of regulatory policies, procedures, and SOPs
• Collect and organize information from quality, clinical, and preclinical teams for submissions
• Coordinate documentation and data for internal reviews and regulatory filings
• Support meeting preparation and communications with internal stakeholders and regulatory bodies
  
  

What You Need

Basic Qualifications:

• Bachelor’s degree in Engineering, Science, or a related field
• 0+ years of experience
  
  

Preferred Qualifications:

• Experience in Regulatory Affairs
• Familiarity with medical device regulations and FDA 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.