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

Stryker is hiring a Staff Specialist, Adverse Event Reporting Divisional Process Owner (Hybrid) to be the vanguard of excellence within our esteemed Instruments Division , who will be the guardian of regulatory adherence, you'll lead the charge in fortifying our adverse event reporting processes to meet and exceed the rigorous standards set by governing bodies. In this hybrid role, you'll be more than just a compliance champion - you'll be a catalyst for innovation and efficiency. With your finger firmly on the pulse of regulatory updates, you'll spearhead transformative changes, ensuring our reporting processes remain at the peak of effectiveness.

Who we want:

• 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, by identifying root causes, evaluating optimal solutions, and recommending comprehensive solutions to prevent future issues.

What you will do:

• Ensure compliance with regulatory requirements for adverse event reporting (AER), including updates and changes.

• Support audits related to AER, MDR, and MIR records.

• Assist in quarterly VMSR submissions and NC/CAPA activities.

• Participate in GPO calls and MIR Forum sub-team meetings.

• Lead Monthly Late AER Board documentation and present metrics at QRB meetings.

• Develop procedures for AER, provide training, and conduct risk assessments.

• Act as primary liaison with regulatory agencies for AER.

• Implement quality assurance measures for AER reports.

• Continuously improve AER process and regulatory compliance.

• Manage annual licenses, registrations, and listings.

• Ensure regulatory compliance in advertising, post-market requirements, and product safety reporting.

• Handle regulatory strategy, recalls, and communication with stakeholders.

• Provide regulatory input throughout the product lifecycle.

• Identify and address regulatory obstacles and market access requirements.

• Evaluate products for regulatory classification and jurisdiction.

• Determine submission requirements and compliance activities.

• Provide regulatory guidance for product development.

• Negotiate with regulatory authorities.

• Develop and implement new regulatory procedures and SOPs.

• Train stakeholders on regulatory requirements and assist in SOP development.

What you will need

• Bachelor's degree required, preferred in a Science or Engineering discipline.

• Minimum of 5 years' experience in post market surveillance and/or Adverse Event Reporting (AER).

• Demonstrated adept project management skills, focusing on technical and scientific regulatory tasks.

• Proficient in regulatory pathways, risk-benefit analysis, and effective communication both internally and externally.

• Executes tasks from submission to post-marketing surveillance, ensuring compliance and documentation.

• Works independently under general supervision, overseeing assignments, reviewing progress, and suggesting procedural changes.

• Exercises autonomy in decision-making, while seeking diverse perspectives and embracing feedback for continuous improvement.

• Capable of directing specialist teams and navigating organizational dynamics to achieve desired outcomes.

• Proactively seeks challenging opportunities for personal and professional growth.

About Stryker

Our benefits:

• 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.

For a more detailed overview of our benefits or time off, please follow this link to learn more: US Stryker employee benefits (https://cdn-static.findly.com/wp-content/uploads/sites/1427/2023/09/20143933/us-stryker-employee-benefits.pdf)

About Stryker

Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 130 million patients annually. More information is available at stryker.com. (http:)

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 on our referral page (https://careers.stryker.com/referrals/)

Stryker is driven to work together with our customers to make healthcare better. Employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required, depending on customer requirements, to obtain various vaccinations as an essential function of their role.

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.