Regulatory Affairs Specialist

Work Flexibility: Hybrid or Onsite

Join Stryker as a Regulatory Affairs Specialist in Bloomington MN supporting Trauma & Extremities. This role provides hands-on exposure to sustaining regulatory activities documentation and global compliance across U.S. and international markets. You will support the ongoing maintenance of product registrations evaluate changes and contribute to regulatory systems and documentation.

What you will do

• Collect organize and maintain regulatory intelligence and documentation for local regional and global requirements

• Research applicable regulations guidance and standards to support product classification submission strategies and compliance activities

• Support audit readiness activities by preparing technical documentation ensuring traceability and maintaining data accuracy across systems

• Assist in the development review and maintenance of regulatory procedures and standard operating procedures

• Review change documentation to assess regulatory impact on released products and document outcomes

• Support change control activities within PLM systems including coordinating documentation updates routing change orders and ensuring appropriate reviewers and approvers are assigned

• Support preparation of regulatory submissions including dossiers pre-submissions and agency packages

• Support the maintenance and alignment of product and regulatory data (e.g. UDI and registration data) to ensure compliance across global markets

• Provide regulatory input for audits inspections and nonconformance activities and support follow-up actions

What you will need

Required Qualifications

• Bachelors degree required. Preferred in Engineering Life Sciences or a related field

• 0 years of experience

Preferred Qualifications

• Masters degree in Regulatory Science or related field

• Demonstrated experience (academic internship or co-op) supporting regulatory documentation submissions or compliance activities in a regulated environment

• Exposure to U.S. FDA regulations or international medical device regulations

• Experience working with data or systems in a regulated environment preferred

US5: $76100 - $126900 USD Annual

View the U.S. work location and transparency guide to find the pay range for your location.

Travel Percentage: 0%

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 contractors legal duty to furnish information.