Vacancy expired!
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-teamWe 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.comStryker 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 www.stryker.comWho 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 doThe 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 evaluated
Establish annual budgets and quarterly forecasts
Make necessary changes with appropriate management involvement
Communicate and collaborate with Quality Assurance, R&D, Service, Global Supply, Finance, Sales, and Marketing departments to ensure corporate goals and strategies are met
Serve as Subject Matter Expert for regulatory processes
Provide guidance, recommendations, and implementation plans for adherence to new regulatory requirements or expectations
Establish standard process to ensure appropriate resolution and management of the responsible task owner
Chair meetings required to drive closure of regulatory issues
Manage and provide updates for regulatory metrics
Implement appropriate enhancements
Represent regulatory processes during internal and external audits
Define targets, KPIs, performance objectives, etc. for individuals within functional role, and manage direct reports to meet or exceed these targets
Recruit, select, and on-board top talent
Develop talent within team to increase performance
Actively address performance issues on team
Maintain a high level of team engagement
Participates in advocacy activities of a more advanced technical and/or tactical or strategic nature
What you need
BS in a science, engineering or related required
Minimum of 9 years' experience required
3 years of supervisory experience preferred
Master's Degree or equivalent preferred
RAC desired
About StrykerOur 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 StrykerStryker 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.
Full-time