Regulatory Compliance Specialist

COVID-19 vaccination requirements

Stryker is driven to work together with our customers to make healthcare better. In order to fulfill our commitment as a federal contractor, while focusing on the health and safety of our employees and those that we serve, Stryker is encouraging US employees as well as all new US employees joining our company to be fully vaccinated against COVID-19. Today or in the future, vaccination may be a requirement based on the essential functions of the specific role or applicable regulations. Please refer to our COVID-19 Vaccination Requirements FAQs page for current vaccination and/or reasonable accommodation requirements and timelines.

Why join Stryker?

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

Our benefits include 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.

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.

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

We are currently seeking a Regulatory Compliance Specialist to join our Endoscopy Division to be based in Flower Mound, TX.

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.

• Meticulous documenters. Detail-oriented people who enjoy maintaining meticulous documentation of reports, metrics, proposals, and presentations.

• Self-directed initiators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.

• 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.

What you will do

As the Regulatory Compliance Specialist, you will be responsible for supporting post-market regulatory reporting activities, including but not limited to coordinating communications between Stryker and global regulatory agencies, adverse event reporting, and ensuring product compliance. You will also be responsible for participating in and leading high-level cross-functional projects and initiatives from planning through close-out, including the development and maintenance of dashboards and metrics to monitor the project status. To ensure continuous process improvement and efficiency, you will also be expected to participate and/or lead various projects and initiatives with the team as well as our cross-functional partners.

• Review complaints for potentially reportable adverse event status, including evaluation and follow-up regarding MDR/MIR reporting.

• Approve complaint records prior to closure to ensure records are compliant with all relevant regulatory requirements.

• Manage Complaint and MDR/MIR approval to ensure internal and regulatory timelines is being met.

• Manage/hold meetings with intra/inter departmental groups.

• Independently manage recall(s).

• Utilize sound independent judgment to analyze areas for improvement and act on them.

• Own corrective and/or preventive actions.

• Work from verbal and/or written instructions.

• Knowledge of applicable international regulations and standards (QSR, MDD, ISO 13485, CMDCAS, etc.) and willingness to train others in quality assurance/GMP-related topics

• Develop and maintain positive relationships with regulatory agencies through professional oral and written communications.

• Communicate directly with customers and regulatory agencies regarding reported complaints and resolutions.

• Work with other departments on known and emerging issues to make quality improvements.

• Participate in Internal and External Audits.

• Serve as Divisional Process Owner for Complaint Handling, Adverse Event Reporting

What you need

• A minimum of a Bachelor’s Degree (B.S. or B.A.) required, preferably in Science, Engineering or related field of study.

• A minimum of 1 year of experience as a Regulatory or Quality professional in a regulated manufacturing environment, preferably Medical Devices.

• Experience with MDR/MIR reporting preferred.

• Applied knowledge of US and International Medical Device Regulations and Standards including but not limited to FDA: CFR 21 Part 803 (MDR), and CFR 21 Part 820 (QSR), MEDDEV 2.12-1 (Guidelines on Medical Device Vigilance System), ISO 13485 (International Organization for Standardization) preferred.

• Knowledge of applicable and international regulations and standards preferred.

• Demonstrated problem-solving and troubleshooting skills.

• Proficient with Microsoft Office and ability to learn Corporate systems.

• Ability to interface with both technical and non-technical personnel at all organizational levels.

• Demonstrate organizational, problem-solving, and analytical and time management skills.

• Ability and versatility to manage changing priorities and workflow for multiple projects and deadlines.

• Ability to understand and explain regulatory compliance 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.

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/

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 one of the World’s Best Workplaces and a Best Workplace for Diversity by Fortune Magazine! Learn more about our award-winning organization by visiting stryker.com