Regulatory Affairs Specialist

Stryker • Portage, MI

1d • $72,500 - $120,900 • Hybrid

About The Position

Join Stryker's Instruments business as a Regulatory Affairs Specialist and support regulatory activities for products used across a broad portfolio of surgical and medical technologies. In this role, you will help maintain regulatory compliance, support submission activities, and provide regulatory intelligence that enables products to meet global market requirements. This is an excellent opportunity for an early-career professional to develop foundational regulatory affairs expertise while partnering with cross-functional teams in a highly regulated environment.

Requirements

• Bachelor’s degree required. Preferred to be in Engineering, Science, Regulatory Science, or a related technical field.
• Demonstrated ability to work with technical, scientific, or regulated documentation through academic, internship, co-op, or professional experience.

Nice To Haves

• Experience supporting regulatory affairs, quality, clinical, research, or compliance activities in a regulated industry.
• Familiarity with medical device, pharmaceutical, biotechnology, or other regulated industry regulations and standards.

Responsibilities

• Monitor regulatory requirements, guidance documents, and industry standards across applicable global markets.
• Research and compile regulatory requirements, approval pathways, and compliance information for products and programs.
• Collect, organize, and maintain regulatory intelligence files, submission documentation, and supporting records.
• Assist in preparing regulatory dossiers, pre-submission packages, and submission materials for regulatory agencies.
• Track regulatory submissions and applications under review and provide status updates to stakeholders.
• Maintain records of communications, commitments, and outcomes with regulatory authorities and other stakeholders.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level