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 links between global, societal and economic trends; stakeholder concerns and regulatory issues and requirements; and the implications for regulatory strategy.
• Participates in advocacy activities of a more advanced strategic nature.
• Develops and updates global, regional and multicountry regulatory strategy, and aligns regulatory strategies to organizational strategies.
• Provides guidance to integrate regulatory considerations into global product entry and exit strategy.
• Identifies regulatory pathways for initial product designs and provides input to internal stakeholders.
• Analyzes the adequacy of proposed regulatory pathways and strategy for initial product designs and recommends changes or refinements based on initial regulatory outcomes.
• Assesses all requirements and potential obstacles for market access and distribution (federal, provincial/territorial/state, reimbursement, purchasing groups, etc.) and develops solutions to address anticipated obstacles.
• Critically assesses the impact of changing regulations on preapproval and post approval strategies and approaches based on changing regulations.
• Provides in-depth understanding and ability to incorporate regulatory strategies to expedite development for products intended for serious or life-threatening medical conditions or that address unmet medical needs (e.g. orphan, conditional approval, breakthrough therapy)
• Negotiates with regulatory authorities on complex issues throughout the product lifecycle.
• Establishes working relationships and interfaces with multiple government and non-government organizations having an impact on market access and distribution.
• Identifies the need for and manages the development and execution of new regulatory procedures and standard operating procedures.
• Develops and manages programs that train stakeholders on current and new regulatory requirements to ensure organization-wide compliance.
• Provides strategic input and technical guidance on global regulatory requirements to product development terms.
• Evaluates risks of product and clinical safety issues during clinical phases and recommends regulatory solutions.
• Evaluates proposed preclinical, clinical, and manufacturing changes for regulatory filing solutions and proposes plans for changes that do not require submissions.
• Reviews and assesses proposals to regulatory authorities on regulatory paths and clinical plans
• Monitors implementation of regulatory strategies relative to product and clinical safety issues identified during clinical phases.
• Provides knowledge and critical analysis of preapproval inspections, GCP inspections and clinical investigator relationships.
• Provides regulatory guidance on strategy for proposed product claims/labeling.
• Ensures clinical and nonclinical data are consistent with the regulatory requirements and support the proposed product claims.
• Manages electronic (eCTD) and paper registration development.
• Ensures policies and procedures are in place for appropriate internal review and approval of regulatory submissions.
• Leads key negotiations and interactions with regulatory authorities during all stages of the development and review process.
• Prepares cross-functional teams for interactions with regulatory authorities including panel/advisory committees.

• A Bachelor's degree required; in Engineering, Biological Sciences or equivalent focus preferred.
• A minimum of 9 years of working in a FDA regulated industry required.
• A minimum of 7 years of Regulatory Affairs experience required.
• 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 required.
• 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.

• $131,400- $215,000salary plus bonus eligible + generally eligible for short-term and long-term financial incentives + 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.