Manager, Regulatory Affairs,
2 weeks ago
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:
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 is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in Medical and Surgical, 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
Who we want
Effective communicators. People who can interpret information clearly and accurately to concisely communicate results and recommendations to stakeholders, senior management, and their teams.Network builders. Managers who build connections with other teams and divisions and coordinate cross-functional collaboration.Managers who drive performance. People who implement process improvements and leverage the talent of their team to consistently increase performance and productivity.Quality-focused team drivers. People who push their team to deliver the highest quality products and solutions in a timely manner.We are currently seeking a Manager, Regulatory Affairs to join our Medical Division. This is a hybrid role based in Portage, Michigan.
What you will do
The Manager, Regulatory Affairs (RA) works with a high level of autonomy to oversee the regulatory process for products requiring governmental approval, including filing necessary applications and handling government interactions to bring medical devices to market and ensure ongoing compliance while managing a regulatory team. In this role, you will;
Manage day-to-day regulatory processes to ensure issues are appropriately evaluatedEstablish annual budgets and quarterly forecastsMake necessary changes with appropriate management involvementCommunicate and collaborate with Quality Assurance, R&D, Service, Global Supply, Finance, Sales, and Marketing departments to ensure corporate goals and strategies are metServe as Subject Matter Expert for regulatory processesProvide guidance, recommendations, and implementation plans for adherence to new regulatory requirements or expectationsEstablish standard process to ensure appropriate resolution and management of the responsible task ownerChair meetings required to drive closure of regulatory issuesManage and provide updates for regulatory metricsImplement appropriate enhancementsRepresent regulatory processes during internal and external auditsDefine targets, KPIs, performance objectives, etc. for individuals within functional role, and manage direct reports to meet or exceed these targetsRecruit, select, and on-board top talentDevelop talent within team to increase performanceActively address performance issues on teamMaintain a high level of team engagementParticipates in advocacy activities of a more advanced technical and/or tactical or strategic natureWhat you need
BS in a science, engineering or related requiredMinimum of 9 years’ experience required3 years of supervisory experience preferredMaster's Degree or equivalent preferredRAC desiredAbout 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
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
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
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.
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