Stryker
Location
Portage, MI | 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 Instruments is seeking an entry-level Regulatory Affairs Specialist to be based hybrid two days per week in Portage, MI.
In this role you will drive product portfolio expansion and operation efficiency, and enhance the impact of innovative healthcare technologies on patients and healthcare professionals.
Why come to Stryker? Dozens of Reasons To Love Stryker
Who we want
Dedicated achievers. Relentless about quality, 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, information, use cases, and industry analyses to develop best practices.
What you will do
As the Regulatory Affairs Specialist , you will identify information sources and resources for local, regional, and global regulations. You will be responsible for compiling and organizing materials for pre-submission reports and communications.
Collects, organizes, and maintains files on local, regional, and global regulatory intelligence and other related information
Monitors the regulatory environment (specific regulations, guidance and other relevant information by product types, geography, etc.)
Provides information used to evaluate products for regulatory classification and jurisdiction
Researches requirements (local, national, international), applicable guidance and standards and options for regulatory submissions, approval pathways, and compliance activities
Assists in the development of regulatory procedures and SOPs
Collects and organizes information on requirements for regulatory, quality, preclinical, and clinical data to meet applicable regulations
Assists in the preparation of dossiers and pre-submission and submission packages for regulatory agencies
Tracks the status of applications planned or under regulatory review and provides updates to the regulatory team
Maintains logs of communication and outcomes with regulators and other relevant internal or external stakeholders
Assists in the scheduling of meetings with internal stakeholders and regulators and develops and organizes materials for these meetings
Clearly conveys information to peers, supervisors, and other stakeholders in written and verbal communications
Seeks out diverse ideas, opinions, and insights, and applies them in the workplace
Embraces scrutiny and accepts feedback as opportunity to learn and improve
What you need
Bachelor’s degree required, preferably in Engineering, Science or related area
0-2 years relevant experience required
Basic understanding of regulatory practices preferred
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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