Job Information
Stryker Staff International Regulatory Affairs Specialist (Hybrid) in Cary, Illinois
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, as well other great perks. For an overview of our benefits and time off, please follow this link to learn more: US Stryker employee benefits. (https://d25zu39ynyitwy.cloudfront.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, Orthopedics 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
We are currently seeking a Staff International Regulatory Affairs Specialist to join our Medical Division based Hybrid in Cary, Illinois.
Who we want
Self-directed initiators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.
Strategic thinkers. People who enjoy analyzing data or trends for the purposes of planning, forecasting, advising, budgeting, reporting, or sales opportunities.
Collaborative partners. People who build and leverage cross-functional relationships to bring together ideas, data, and insights to drive continuous improvement in functions.
Analytical problem solvers. People who go beyond just fixing to identify root causes, evaluate optimal solutions, and recommend comprehensive upgrades to prevent future issues.
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.
What you will do
As the Staff International Regulatory Affairs Specialist , you will develop and apply basic knowledge and understanding of global regulatory and legal frameworks, regulatory requirements, legislation, processes, and procedures used to evaluate proposed products for regulatory classification and registration. You will research requirements (local, national, international), applicable guidance and standards, and options for regulatory submissions, approval pathways, and compliance activities. In this role you will:
Identify information sources and resources for local, regional, and global regulations.
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 proposed products for regulatory classification and jurisdiction.
Research 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.
Organizes materials from preclinical and clinical studies for review and assists in the review process.
Compiles and organizes materials for pre-submission reports and communications.
Assists in the preparation of dossiers and pre-submission and submission packages for regulatory agencies.
Tracks the status of applications 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.
What you need
A Bachelor’s Degree (B.S or B.A) in Engineering, Science or equivalent focus is required.
5+ years of experience in an FDA-regulated industry required, preferably with medical devices and formulations.
2-3 years of Medical Device Regulatory Affairs experience required.
RAC certification or Advanced Degree (Masters in Regulatory Affairs) preferred.
Thorough understanding of FDA and international medical device regulations.
General understanding of product development process and design control.
General understanding of regulations applicable to the conduct of clinical trials.
Previous experience with Class II/III medical devices required.
Previous experience drafting regulatory submissions to FDA required.
Experience interacting with regulatory agencies required.
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.