Stryker
Location
Redmond, WA | United States
Job description
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 currently seeking a Staff Regulatory Compliance Engineer to support our Emergency Care division. This is a hybrid role based Monday, Tuesday, and Wednesday onsite in Redmond, WA.
Who we want
Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data and insights to drive continuous improvement in functions.
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.
Self-directed initators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.
What you will do
As the Staff Regulatory Compliance Engineer , you will manage the evaluation of new and revised international safety standards and regulations. You will be responsible for all aspects of Regulatory Intelligence processes from initiation to completion interacting with cross-functional stakeholders, projects teams, and other departments.
Assess regulatory intelligence to assist in the development of local, regional, and global regulatory strategies and update strategies based upon regulatory changes
Evaluate the regulatory environment and contribute to providing internal advice throughout the product lifecycle to ensure product compliance
Lead the identification, assessment, monitoring, and closure of applicable new or revised standards, regulations, directives, implementing decisions and common specifications to assure postmarket regulatory requirements are met
Participate in implementation of regulatory strategy and processes
Assign individual responsibilities, work with departmental managers to identify appropriate resources needed, and develop schedules to ensure timely completion of assigned actions
Record detailed requirements, actions, and deliverables
Ensure a common understanding by setting expectations in accordance with regulatory requirements to align stakeholders and leadership
Measure performance using appropriate tools and techniques in order to monitor progress
Help train stakeholders on current and new regulatory requirements to ensure organization-wide compliance
What you need
Bachelors Degree required, preferably in Business, Engineering, or Science
Masters Degree in Regulatory Science/Regulatory Affairs preferred
Minimum 4 years’ experience with safety standards, product compliance and certifications required
Familiarity with IEC standards for medical devices, such as IEC 60601-1 and IEC 60601-2-4, ISO 17025, ISO 14971, ISO 13485, CE-Mark, CB Scheme preferred
Familiarity with international regulations, such as 21 CFR 820, MDD, EU-MDR, RED, Low Voltage Directive 2014/35/EU (LVD), SOR 98-282, Australian Therapeutic Goods Act (TGA), Brazil RDC’s, MHLW Ministerial Ordinance No. 169 preferred
Strong project management, writing, coordination, and execution of regulatory items
Emphasis on technical and scientific regulatory activities
Ability to analyze and correct process and /or system issues of a broad scope using independent judgement
Excellent interpersonal communication, collaborative teamwork and negotiation skills
Ability to seek out diverse ideas, opinions, insights and apply to processes
$98,300 – $161,100 salary plus bonus eligible + benefits. Actual minimum and maximum may vary based on location. Individual pay is based on skills, experience, and other relevant factors.
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 stryker.com.
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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