Work Flexibility: Remote or Hybrid or Onsite

Regulatory Affairs Specialist – Lower Extremities/Biologics

Memphis, TN

Stryker is looking for a Regulatory Affairs Specialist to join our Trauma & Extremities Biologics team. In this role, you will help bring innovative soft tissue and biologic medical technologies to market while ensuring compliance with global regulatory requirements. You will work independently and cross-functionally to drive strategic regulatory initiatives, prepare submissions, and interact with regulatory agencies and internal partners.

Work Flexibility: Hybrid

Candidates must reside within a commutable distance to Memphis, TN, and be available to work onsite two days per week.

What You’ll Do

Prepare regulatory submissions and pre-submission materials for global health authoritiesResearch global regulatory requirements, standards, and approval pathways to support product development and complianceSupport development and maintenance of regulatory policies, procedures, and SOPsCollect and organize information from quality, clinical, and preclinical teams for submissionsCoordinate documentation and data for internal reviews and regulatory filingsSupport meeting preparation and communications with internal stakeholders and regulatory bodies

What you need

Basic Qualifications:

Bachelor’s degree in Engineering, Science, or a related field0+ years of experience

Preferred Qualifications:

Experience in Regulatory AffairsFamiliarity with medical device regulations and FDA requirements

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.