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

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

Our benefits include bonuses; healthcare; insurance benefits; retirement programs; stock based 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.

We are currently seeking a Senior Regulatory Compliance Specialist to join our Trauma and Extremities Division to be based in Mahwah, NJ or remotely within the United States.

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.

• 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 you will do

As the Senior Regulatory Compliance Specialist, you will review and assess all incoming product complaints according to the regulatory requirements governing MDR reporting to determine if the event meets reporting criteria. For reportable events, you will be expected to ensure reports are well-written and submitted to the applicable agency within the required timeframes. For events that do not meet reporting criteria, you will utilize data from risk table documentation and/or liaise with clinicians and subject matter experts to compose a comprehensive rationale for not reporting the event to Regulatory Agencies. Additionally, you will be responsible for addressing various inquiries from global Regulatory Agencies through direct communications and various regulatory audits. 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.

• Electronically process customer complaints to determine adverse event reportability.

• Complete electronic submission of MDRs and MIRs reports.

• Utilize risk management process to determine potential and actual risk related to complaint events.

• Work with senior staff to respond to additional Information requests from Global Regulatory Agencies.

• Review and input into standard operating procedures (SOPs).

• Maintain compliance to regulations.

• Provide correspondence to regulatory agencies under close supervision.

• Participate in internal regulatory and quality audits as assigned.

• Communicate with internal and external resources globally.

• Ensure complaints are classified correctly and that all supporting data for investigations are adequately documented and attached to the complaint file.

• Monitoring impact of changing regulations.

What you need

• A minimum of a Bachelor’s Degree (B.S. or B.A.) required.

• A minimum 3 years of experience as a Regulatory or Quality professional in a regulated manufacturing environment is preferred.

• Experience with Post-Market MDR/MIR reporting is desirable.

• 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), etc. preferred.

• Experience with MDR/MIR reporting preferred.

$73,100 - $152,400 salary plus bonus eligible + Benefits (Health, Vision, Dental, 401K, Tuition Reimbursement, Employee Assistance Program, Wellbeing Program, Employee Stock Purchase Program). This information reflects the anticipated salary range for this position based on current national data. Actual minimum and maximum may vary based location. Individual pay is based on skills, experience, and other relevant factors.

About Stryker

Stryker is one of the world’s leading medical technology companies and, together with our customers, is driven to make healthcare better.

The company offers innovative products and services in Medical and Surgical, Neurotechnology, Orthopedics, and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 100 million patients annually.

More information is available at stryker.com