Staff International Regulatory Affairs Specialist (Hybrid) - Illinois, Cary 3909 Three Oaks Rd

Work 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, 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.

 

Travel Percentage: 10%

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.

Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.