Senior Specialist, Regulatory Affairs
Stryker is hiring a Senior Specialist, Regulatory Affairs to join our Smart Care team. Join a team that supports regulatory initiatives across the product lifecycle, including software, sustaining, and environmental regulatory activities, to help ensure products remain compliant with applicable global regulatory requirements. This role partners with cross-functional teams to assess regulatory implications, support compliance and regulatory strategy activities, and provide regulatory guidance that informs product and business decisions.
Workplace Flexibility: Strong preference will be given to candidates who reside within a commutable distance of Portage, Michigan and can work a hybrid schedule.
What You Will Do
Support development, review, and maintenance of regulatory procedures and documentation.
Contribute to regulatory strategies and recommend updates based on evolving regulations, guidance, and industry standards.
Assess and support compliance with global regulatory and environmental requirements, evaluating potential impacts of evolving regulations on products, processes, and business activities.
Provide regulatory input for product development, lifecycle management, and change planning activities.
Evaluate regulatory requirements and potential impacts for new products, product modifications, and business initiatives.
Research and assess regulatory history, product classifications, and therapeutic or diagnostic landscapes to identify regulatory pathways and considerations.
Identify potential regulatory risks, trade-related considerations, and approval challenges, and communicate findings to project teams.
Define submission, registration, and approval requirements and support preparation of regulatory deliverables.
Participate in risk-benefit assessments and compare regulatory outcomes against original product concepts to support future recommendations and regulatory planning.
What You Will Need
Required Qualifications
Bachelor's degree required. Preferred in Regulatory Affairs, Engineering, Life Sciences, Biological Sciences, or a related field.
Minimum 2 years of experience in regulatory affairs within the medical device, biotechnology, pharmaceutical, healthcare industry, or other regulated industries.
Preferred Qualifications
Experience supporting regulatory activities for software products, including Software as a Medical Device (SaMD) and/or non-medical software solutions.
Experience assessing and supporting compliance with environmental regulations and reporting requirements.
Experience supporting products throughout the full product lifecycle, including development, commercialization, and post-market activities.
Regulatory Affairs Certification (RAC).
Master's degree in Regulatory Affairs, Engineering, Life Sciences, or a related discipline.
United States of America Pay Ranges:
- USN: $83,300 - $138,800 USD Annual
- US5: $87,500 - $145,700 USD Annual
- US10: $91,600 - $152,700 USD Annual
- US15: $95,800 - $159,600 USD Annual
- US20: $100,000 - $166,600 USD Annual
- US30: $108,300 - $180,400 USD Annual
View the U.S. work location and transparency guide to find the pay range for your location.
Travel Percentage: 20%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.