Staff Regulatory Affairs Specialist

About Stryker

Stryker is one of the world’s leading medical technology companies and, together with our customers, is driven to make healthcare better. We offer innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes.

We are proud to be named the #5 World’s Best Workplaces and a Best Workplace for Diversity by Fortune Magazine. Learn more about our award-winning organization by visiting stryker.com

Why regulatory affairs/quality assurance 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 Regulatory Affairs 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 team: https://www.strykercareersblog.com/post/10-reasons-to-join-strykers-regulatory-affairs-team

Stryker is seeking to hire a Staff Regulatory Affairs Specialist for Stryker’s Endoscopy Division. This position will be located in Flower Mound, Texas or remote if desired by the candidate.

Stryker’s Endoscopy division is focused on advancing minimally invasive surgery and Operating Room configuration. Products include: cameras, joint repair implants and operating room tables, booms and lights.

WHO WE WANT:

• Detail-oriented process improvers. Critical thinkers who naturally see opportunities to develop and optimize work processes – finding ways to simplify, standardize and automate.
• 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.

WHAT WILL YOU DO:

This position is responsible for serving on the Regulatory Operations leadership team, collaborating across the Post Market RA, International RA and Technical Publications team to serve on or own projects that aim to drive compliance with new regulations, implement continuous improvement initiatives and drive cross functional, cross divisional or cross business unit objectives impacting the regulatory affairs organization.

• Leads projects which serve to develop, apply, and revise procedures to maintain and improve quality compliance and standards as well as review and approve concessions, non-conforming product and corrective actions as denoted by applicable regulations and procedures
• Guides others in application of understanding of industry practice, domestic and international regulations and company policies to effectively implement and improve product quality and the quality management system
• Responsible for approving records such as investigations, reportability decisions, health hazard evaluations, hold and recall documentation for events associated with product within the divisional product portfolio.

WHAT YOU NEED: FROM THE REQUISITION

Education/Special Training Required

• BS level degree or equivalent in Biostatistics, Statistics, or related field

Qualifications/Work Experience Required

• Review and approve investigations of returned products and/or related reports including reportability decisions
• Draft reports or inquiries requiring submission to regulatory agencies as appropriate
• Lead conversations with regulatory agencies on adverse event reporting, vigilance reports, recall activity or regulation based projects.
• Serve as subject matter expert on panels or industry groups responsible for providing feedback on changing regulations.
• Lead projects that aim to drive continuous improvement in processes, procedures or work of RA or divisional teams.
• Own, review and approve non-conformances and planned deviations
• Review and analyze data for trending purposes
• Recommend corrective and/or preventive actions to address non-conformities and deviations
• Work from verbal and/or written instructions.
• Lead development of process and product protocols and reports
• Lead development of statistical process controls and analyzing data
• Act independently to determine daily activities and project implementation
• Provide leadership, training and mentorship to team members and cross-functional teams

• Must be able to analyze and resolve non-routine product issues using independent judgment with the assistance of engineering support when required
• Working knowledge of data collection, data analysis, evaluation, and scientific method.
• Engineering schematics/drawing/prints reading and interpretation
• Commitment to excellence and high standards
• Excellent organizational, problem-solving, and analytical skills to lead to sound, timely decisions
• Ability and versatility to manage changing priorities and workflow for multiple projects and deadlines
• Ability to interface with both technical and non-technical personnel at all organizational levels.
• Proficient with Microsoft Office and ability to learn corporate systems.
• Ability to understand and explain detailed regulatory compliance programs and/or issues.
• Ability to comply with constantly changing regulatory procedures and prioritize work effectively.
• Ability to analyze and resolve non-routine regulatory issues using independent judgment.
• Must be able to observe and correct minute inconsistencies (e.g. in the written word, form usage, etc.).
• Self-motivated.

WHAT YOU NEED:

• 5+ years of relevant work experience is required.
• Bachelor’s or Master’s degree in engineering, life sciences or nursing (mechanical, electrical, industrial, software, biomedical, computer, biology, physics, chemistry, etc.) preferred.
• Previous experience in legal, technical or medically related area preferred.

• Knowledge of applicable international regulations and standards (CFR, MDD/EU MDR, QSR, ISO 13485, CMDCAS, etc.)
• Regulatory Affairs Certification desired

#LI-Remote

Our benefits

Our total rewards offering varies by country but often includes bonuses; commissions; healthcare; insurance benefits; retirement programs; stock based plans; paid time off plans; family and parenting leaves; tuition reimbursement; wellness programs; onsite fitness centers and cafeterias; discount purchase programs; and service and performance awards – not to mention various social and recreational activities.

Know someone at Stryker?

Be sure to have them submit you as a referral prior to applying for this position. Learn more about our employee referral program at https://careers.stryker.com/referrals/