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.

• Assesses regulatory intelligence to assist in the development of local, regional, and global regulatory strategies.
• Evaluates the regulatory environment and contributes to providing internal advice throughout the product lifecycle (e.g., concept, development, manufacturing, marketing) to ensure product compliance.
• Anticipates regulatory obstacles and emerging issues throughout the product lifecycle and develops solutions.
• Identifies requirements and potential obstacles for market access distribution (federal, provincial/territorial state, reimbursement, purchasing groups, etc.)
• Assists in the development of regulatory strategy and updates strategy based upon regulatory changes
  Evaluates proposed products for regulatory classification and jurisdiction.
• Determines 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.
• Compares regulatory outcomes with initial product concepts and recommends changes or refinements based on initial regulatory outcomes.
• Negotiates with regulatory authorities throughout the product lifecycle.
• Identifies the need for new regulatory procedures, SOPs, and participates in development and implementation.
• Helps train stakeholders on current and new regulatory requirements to ensure organization-wide compliance.
• Assists other departments in the development of SOPs to ensure regulatory compliance.
• Provides regulatory input and technical guidance on global regulatory requirements to product development teams.
• Advises stakeholders of regulatory requirements for quality, preclinical, and clinical data to meet applicable regulations.
• Assesses the acceptability of quality, preclinical, and clinical document for submission filing to comply with applicable regulations.
• Evaluates proposed preclinical, clinical, and manufacturing changes for regulatory filing solutions and proposes plans/strategizes (if appropriate) for changes that do not require submissions.
• Provides knowledge and guidance on preapproval inspections, GCP inspections, and clinical investigator relationships.
• Identifies, monitors, and submits applicable reports or notifications to regulatory authorities during the clinical research process.
• Provides regulatory information and guidance for proposed product claims/labeling.
• Ensures that the clinical and nonclinical data, in conjunction with regulatory strategy, are consistent with the regulatory requirements and support the proposed product claims.
• Prepares and submits electronic and paper regulatory submissions according to applicable regulatory requirements and guidelines.
• Monitors the progress of the regulatory authority review process through appropriate communications with the agency.
• Communicates and interacts with regulatory authorities before and during the development and review of a regulatory submission through appropriate communication tools
• Works with cross-functional teams for interactions with regulatory authorities including panel meetings and advisory committees.

• A minimum of a Bachelor's Degree (B.S. or B.A.) in Science, Engineering or equivalent focus required.
• A minimum of 5 years of experience in an FDA or highly regulated industry required.
• A minimum of 2-3 years in a Regulatory Affairs role required.
• Experience with software as a medical device, Agile development, and/or artificial intelligence preferred.
• RAC(s) desired

• $83,000- $136,000 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.