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

• Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes - finding ways to simplify, standardize and automate.
• Meticulous documenters. Detail-oriented people who enjoy maintaining meticulous documentation of reports, metrics, proposals, and presentations.
• 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.
• Curious learners. People who seek out cutting-edge research and information to expand and enhance their ability to develop new ideas into reality.

• Preparation and submission of post-market reports and submissions (MDRs and MIRs)
• Maintain systems to trigger and log regulatory reporting.
• Track and maintain files on annual licenses, registrations, and listings.
• Maintain systems to track, manage, and report product-associated events.
• Track product complaints, events, and recalls.
• Identify information sources and resources for local, regional, and global regulations.
• Collect, organize, and maintain files on local, regional, and global regulatory intelligence and other related information.
• Monitor the regulatory environment (specific regulations, guidance and other relevant information by product types, geography, etc.).
• Provide 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.
• Assist in the development of regulatory procedures and SOPs.

• Bachelors Degree required.
• 2+ years' professional experience.
• 2+ years medical device preferred.
• Strong time management, writing, coordination, and execution skills.
• Excellent analytical and writing skills.
• Excellent interpersonal, written and oral communication skills.
• Effective organizational skills.
• Advanced PC skills with proficiency in Microsoft office Suite, including Excel.

• 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.