Regulatory Affairs Specialist – Lower Extremities/Biologics Position Available In Shelby, Tennessee

Regulatory Affairs Specialist – Lower Extremities/Biologics Stryker – 3.8

Memphis, TN Job Details Full-time Estimated:

$60.5K – $106K a year 1 day ago Benefits Health savings account AD&D insurance Employee stock purchase plan Paid holidays Disability insurance Health insurance Dental insurance 401(k) Flexible spending account Vision insurance Prescription drug insurance Qualifications Engineering Bachelor’s degree Entry level FDA regulations Under 1 year Full Job Description Why join Stryker? Looking for a place that values your unique talents? Discover Stryker’s award-winning culture. We are proud to offer you our total rewards package which includes bonuses, healthcare, insurance benefits, retirement programs, wellness programs, as well as service and performance awards – not to mention various social and recreational activities, all of which are location specific. Job description We are excited to be named one of the World’s Best Workplaces by Fortune Magazine! We are proud to offer you 12 paid holidays annually. For an overview of our benefits and time off, please follow this link to learn more:

US Stryker employee benefits. 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.