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 imitators. 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.
• 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.
• Goal-oriented developers. Keeping the customer and requirements squarely in focus, people who deliver safe and robust solutions.

• Participate on Product Supply Support teams to ensure US, EU and other international requirements are incorporated throughout the implementation process of product changes, manufacturing transfers and other special projects
• Support Marketing and Manufacturing teams with regulatory assessments of proposed changes or product transfers.
• Assess regulatory intelligence to assist in the development of local, regional, and global regulatory strategies.
• Participate in advocacy activities of a more advanced technical and/or tactical or strategic nature.
• Evaluate the regulatory environment and contributes to providing internal advice throughout the product lifecycle (e.g., concept, development, manufacturing, marketing) to ensure product compliance.
• Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develops solutions.
• Identify requirements and potential obstacles for market access distribution (federal, provincial/territorial state, reimbursement, purchasing groups, etc.).
• Assist in the development of regulatory strategy and updates strategy based upon regulatory changes.
• Evaluate proposed products for regulatory classification and jurisdiction.
• Determine requirements (local, national, international) and options for regulatory submission, approval pathways, and compliance activities.
• Provide regulatory information and guidance for product development and planning throughout the product lifecycle to the regulatory groups and others within the organization.
• Compare regulatory outcomes with initial product concepts and recommends changes or refinements based on initial regulatory outcomes.
• Negotiate with regulatory authorities throughout the product lifecycle.
• Identify 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.
• Assist other departments in the development of SOPs to ensure regulatory compliance.
• Provide regulatory input and technical guidance on global regulatory requirements to product development teams.
• Advise stakeholders of regulatory requirements for quality, pre-clinical, and clinical data to meet applicable regulations.
• Assess the acceptability of quality, pre-clinical, and clinical document for submission filing to comply with applicable regulations.
• Evaluate proposed pre-clinical, clinical, and manufacturing changes for regulatory filing solutions and proposes plans/strategizes (if appropriate) for changes that do not require submissions.
• Provide knowledge and guidance on pre-approval inspections, GCP inspections, and clinical investigator relationships.
• Identify, monitor and submit 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.
• Previous experience with Class II/III medical devices preferred.
• Previous experience drafting 510(k)s preferred.
• RAC certification or Advanced Degree (Masters in Regulatory Affairs) preferred.
• Experience authoring regulatory submissions for product approval preferred.
• Experience interacting with regulatory agencies preferred.
• Ability to comply with constantly changing regulatory procedures and prioritize work effectively.
• Ability to analyze and resolve non-routine regulatory issues using independent judgment.
• 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.