We are seeking a Staff Regulatory Affairs Specialist to join our Medical Division - Acute Care in Portage, MI (Hybrid).
As a Staff Regulatory Affairs Specialist, you will support Stryker’s global Acute Care portfolio by maintaining market access and ensuring compliance with evolving regulatory requirements. You will assess device changes, monitor emerging regulatory intelligence, and lead regulatory activities related to wireless technologies. Your work will guide the development, approval, and compliance of innovative medical devices that incorporate wireless communication.
What You Will Do:
Evaluate device modifications and implement actions to maintain global product compliance.
Analyze emerging regulatory intelligence and advise on potential impact to market access.
Provide regulatory input and technical guidance to product development teams for global requirements.
Determine requirements and options for regulatory submissions, approval pathways, and compliance activities.
Prepare and submit regulatory submissions in alignment with global regulations and guidelines.
Participate in audits to enable or maintain market access across international markets.
Identify gaps and contribute to development and implementation of new regulatory procedures and SOPs.
Support wireless technology compliance within medical devices to meet global regulatory standards.
What You Need:
Required:
Bachelor’s degree (B.S. or B.A.) required, preferably in Engineering, Science, or related field.
4+ years of experience in a regulated industry required, preferably with medical devices.
Previous experience in Pre- or Post-Market Regulatory, Clinical, Quality, or Engineering.
Preferred:
RAC certification or advanced degree (e.g., Master’s in Regulatory Affairs).
General understanding of FDA, EU, and international medical device regulations.
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.