Regulatory Affairs Specialist, Customer Quality

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 Affairs Specialist, Customer Quality, to join our Medical Division in Portage, Michigan.

Who we want

• 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.

• Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.

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

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

What you will do

As a Regulatory Affairs Specialist, Customer Quality, you will be responsible for determining whether Stryker products associated with customer complaints either contributed or may have contributed to adverse events, and the subsequent filing of adverse event reports to the appropriate medical device competent authority. In this role, you will be empowered to make decisions which may impact global health authorities’ perspective on Stryker’s products. This role will support Stryker Medical Kalamazoo’s product portfolio which includes hospital beds, powered and non-powered support surfaces, stretchers, ambulance cots and fasteners, and temperature management devices. Additional responsibilities include:

• Review complaints and assess them for regulatory reporting (US <30 days, international agencies as appropriate to the regulations).

• Submit initial and follow-up reports to medical device competent authorities as needed.

• Review and approve complaint investigations and adverse event reports.

• Interact with medical device competent authorities on vigilance reports and incidents globally.

• Collaborate with Quality Engineers and Quality Technicians to gather information for reportability decisions.

• Participate in the coordination and submission of Post Market Surveillance Reports and Periodic Safety Update Reports (PSURs) for the EU, and other summary reporting requirements globally.

• Utilize and assist in the development of regulatory procedures.

• Assist with training other departments on their complaint handling and reporting responsibilities.

• Review Ambulance Accident Evaluations and provide support to customers regarding policy and process.

• Prepare and support internal and external audits.

What you need

• A Bachelor’s Degree (B.S or B.A) required; preferably in Engineering, Science, or equivalent focus.

• Previous experience in medical devices, biologics or pharmaceutical field preferred.

• Previous experience in a Regulatory or Quality role preferred.

• Knowledge of applicable and international regulations and standards preferred.

• Training and/or certifications in regulatory affairs preferred.

• Ability to understand and explain detailed regulatory compliance programs and/or issues.

• Ability to comply with constantly changing regulatory procedures and prioritize work effectively.

• Excellent interpersonal skills with the ability to interface with both technical and non-technical personnel at all organizational levels.

• Excellent written, and oral communication.

• Excellent organizational, problem-solving, attention to detail, analytical, and time management skills.

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