Principal Regulatory Affairs Specialist

Stryker

Principal Regulatory Affairs Specialist supporting Stryker’s medical-device acquisitions and strategic initiatives. Leading regulatory strategy, risk assessment, and lifecycle compliance across cross-functional teams.

Posted 8/19/2026full-timePortage • Missouri • 🇺🇸 United StatesLead💰 $126,500 - $210,700 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Regulatory Affairs and Quality Assurance within FDA-regulated industries, with a strong focus on compliance, risk assessment, and strategic decision-making throughout the product lifecycle.

Highest-signal resume keywords

Regulatory Affairs ExperienceFDA Regulations KnowledgeRegulatory Affairs Certification (RAC)Medical Device Industry ExperienceProduct Lifecycle Management

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Regulatory Strategy DevelopmentRegulatory Compliance RequirementsRisk Mitigation StrategiesProject ManagementRegulatory Due Diligence

Soft Skills

Stakeholder InfluenceCollaborationAnalytical ThinkingCommunication

Certifications & Qualifications

Regulatory Affairs Certification (RAC)

Industry Keywords

FDA-Regulated IndustryMedical DeviceMergers and Acquisitions (M&A)Product DevelopmentCommercialization

About the role

Key responsibilities & impact

Partner with Business Development teams to support regulatory and quality due diligence for potential acquisitions
Research and analyze new technologies, business models, product portfolios, and regulatory landscapes for strategic decision-making
Lead regulatory strategy development and execution for product development, commercialization, and lifecycle management
Collaborate on integration planning following acquisitions
Serve as a regulatory subject matter expert on significant projects
Provide guidance on regulations, standards, and compliance requirements
Monitor global regulatory changes and communicate impacts, risks, and required actions
Evaluate regulatory risks and develop mitigation strategies
Review project progress and regulatory deliverables
Recommend procedural improvements to enhance compliance and efficiency
Translate complex regulatory requirements into actionable project plans and compliance activities

Requirements

What you’ll need

Bachelor's degree required
Degree in Engineering, Biological Sciences or equivalent focus preferred
Minimum 8 years of relevant Regulatory Affairs/Quality Assurance experience within an FDA-regulated industry
Applied knowledge of FDA regulations and regulatory compliance requirements
Regulatory Affairs Certification (RAC) preferred
Master's degree in Regulatory Affairs or related discipline preferred
Medical device industry experience strongly preferred
Experience supporting products throughout the full product lifecycle, including product development, commercialization, post-market activities, and lifecycle management
Experience supporting business development, due diligence, mergers and acquisitions (M&A), licensing activities, or other strategic business initiatives preferred
Ability to assess regulatory and quality risks, navigate ambiguity, and influence stakeholders across complex organizations

Benefits

Comp & perks

Hybrid work flexibility
Career development opportunity
20% travel opportunity