Why RA/QA at Stryker?

Are you interested in working for a global company where you can work across functions and on a wide-variety of projects? As a member of Stryker's RA/QA team, that is exactly what you will do! Here, we provide our RA/QA team the opportunity to learn new things, as well as endless growth opportunities! If you are interested in working at one of the World's Best Workplaces, apply now !

Need another reason to apply? Here are 10 reasons to join our Regulatory Affairs/Quality Assurance team: https://www.strykercareersblog.com/post/10-reasons-to-join-strykers-regulatory-affairs-team

• Possess and apply knowledge and understanding of the regulatory and legal frameworks, processes, and procedures to maintain compliance of a large portfolio of Joint Replacement implant and instrument products
• Determine requirements (local, national, international) and options for regulatory submission, approval pathways, and compliance activities.
• Provides regulatory information and guidance for product development and planning throughout the product lifecycle to the regulatory groups and others within the organization
• Author FDA submissions, EU design dossiers, and other regulatory documents to obtain approval of device modifications
• Communicates and interacts with regulatory authorities before and during the development and review of a regulatory submission through appropriate communication tools
• Monitor the progress of the regulatory authority review process through appropriate communications with the agency.
• Maintain and update EU technical documentations and support technical surveillance audit.
• Assess global impact of changes to launched products. Author and support notifications/submissions.
• Evaluate changing medical device regulations and develop strategies for maintaining products on the market.
• Author and update divisional SOPs, recommend timely changes to ensure regulatory compliance, and lead process improvements to maximize efficiencies.
• Advise and help train stakeholders on current and new regulatory requirements to ensure organization-wide compliance on quality, pre-clinical and clinical requirements
• Review labeling, marketing literature, and promotional materials for compliance with regulatory requirements.
• Review external standards for compliance assessment

• BS in Engineering, Science, or related degree required
• MS or RAC(s) preferred
• 3 years of experience in an FDA or highly regulated industry required
• 2+ years of Medical Device Regulatory Affairs experience required
• Strong project management, writing, coordination, and execution of regulatory items with emphasis on technical and scientific regulatory activities

• 12 paid holidays annually
• 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.