Senior Specialist, Regulatory Affairs

Stryker; Portage (MI); Hybrid; USD 83,000 - 180,000; Full time

Benefits offered by this job

Health benefits

401(k) plan

Wellbeing program

Job summary

Stryker in Portage, MI is seeking a Senior Specialist, Regulatory Affairs to join our Smart Care team. You will work with cross-functional groups to guide regulatory strategy, develop and maintain regulatory documentation, and ensure compliance across software, devices, and environmental requirements.

You will assess regulatory impacts on product development and lifecycle planning, define submission needs, and support risk-benefit assessments.

Qualifications

• Bachelor's degree required; preferred in Regulatory Affairs, Engineering, Life Sciences, or related field.
• Minimum 2 years of experience in regulatory affairs within the medical device, biotechnology, pharmaceutical, healthcare industry, or other regulated industries.

Responsibilities

• Support development, review, and maintenance of regulatory procedures and documentation.
• Contribute to regulatory strategies and 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.
• 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.

Skills

Regulatory affairs

Regulatory strategy

SaMD knowledge

Education

Bachelor's degree

Job description

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.

Required Qualifications

What You Will Need

• 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

Posted Date: 09/01/2026 This role will be posted for a minimum of 3 days.

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

Health benefits include: Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program.

Financial benefits include: Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance.

Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.