Manager, Regulatory Affairs,
4 days ago
We are excited to be named one of the World’s Best Workplaces by Fortune Magazine We are proud to offer you 12 paid holidays annually. For an overview of our benefits and time off, please follow this link to learn more:US Stryker employee benefits. (loudfront.net/oms/000000/document/2024/6/SMVZW\_USStrykerEmployeebenefits/USStrykerEmployeebenefits.pdf) 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 www.stryker.com **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 **Instruments** **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 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 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. Stryker 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 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required 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.
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Associate Manager, Regulatory Affairs
2 weeks ago
Portage, Michigan, United States Stryker Full timeWork Flexibility: Hybrid 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...
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Manager, Regulatory Affairs,
2 weeks ago
Portage, United States Stryker Full timeWhy 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...
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Senior Regulatory Affairs Specialist
3 weeks ago
Portage, United States Stryker Full timeWork Flexibility: Hybrid 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...
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Senior Regulatory Affairs Specialist
1 month ago
Portage, United States Stryker Full timeWhy 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...
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Principal Regulatory Affairs Specialist
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Portage, United States Stryker Corporation Full time**Why RA/QA at Stryker?**: We are currently seeking a** Principal Regulatory Affairs Specialis**t for our Medical division to be based remotely anywhere within the US. **Who we want** - ** Strategic thinkers. **People who enjoy analyzing data or trends for the purposes of planning, forecasting, advising, budgeting, reporting, or sales opportunities. - **...
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Portage, United States Stryker Full timeWhy 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...
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Portage, United States Stryker Full timeWe are excited to be named one of the World’s Best Workplaces by Fortune Magazine! We are proud to offer you 12 paid holidays annually. For an overview of our benefits and time off, please follow this link to learn more:US Stryker employee benefits....
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Engineering Manager
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Portage, Michigan, United States Thermo Fisher Scientific Full timeJob Description Company Information: The ImmunoDiagnostics Division (IDD), is a division within Thermo Ficher Scientific Inc. (NYSE: TMO). IDD develops, manufactures, and markets complete blood test systems to support the clinical diagnosis and follow-up of allergy and autoimmune diseases. The allergy and autoimmunity product lines operate on a common...
