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

• Self-directed initiators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.
• Strategic thinkers. People who enjoy analyzing data or trends for the purposes of planning, forecasting, advising, budgeting, reporting, or sales opportunities.
• Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.
• Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.
• Dedicated achievers. People who thrive in a fast-paced environment and will stop at nothing to ensure a project is complete and meets regulations and expectations.

• Develop and execute global regulatory strategy for new and/or modified medical devices including for expanded indications for use.
• Prepare complex regulatory submissions and/or presentations (i.e., pre-submissions, 510(k)s, Design Dossiers, Technical Files, etc.) to regulatory bodies (i.e., FDA, Notified Bodies, etc.) and for any related communications.
• Lead business unit in revision and/or development of processes/ procedures for, and implementation of, new or revised regulatory requirements based on either changes in business or regulatory requirements.
• Partner regularly with marketing, engineering, clinical and quality on project and product development teams.
• Participate in internal and external regulatory authority audits.
• Serve as a regulatory affairs representative to improve awareness, visibility and communication on regulatory requirements to support company goals and priorities.

• A bachelor's degree required; in Engineering, Biological Sciences or equivalent focus preferred.
• A minimum of 7 years of working in an FDA regulated industry required.
• A minimum of 4 years of Regulatory Affairs experience required.
• Previous experience with Class II Medical Devices with software and AI/ML development preferred.
• Previous experience authoring 510(k)s and other regulatory submissions required.
• Experience interacting with regulatory agencies required.
• RAC certification or Advanced Degree (Masters in Regulatory Affairs) preferred.
• Strong leadership skills.
• Demonstrated success in management of global regulatory strategy and submission activities,
• Demonstrated applied knowledge of FDA and international medical device regulations/standards/directive (i.e. European Medical Device Regulations).
• Ability to understand and explain detailed regulatory requirements among different countries and comply with constantly changing regulatory requirements.
• Adaptable to a fast-paced environment with changing circumstances, direction and strategy and has the desire to thrive in a dynamic environment.
• Strong interpersonal, written and oral communication skills.
• Good time and project management skills with the ability to multi-task.

• $123,000- $204,00 salary plus bonus eligible + benefits. Actual minimum and maximum may vary based on location. Individual pay is based on skills, experience, and other relevant factors.

• 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.