Hybrid Senior Regulatory Strategy Lead – M&A & Lifecycle

Regulatory Jobs; Portage (MI); Hybrid; USD 127,000 - 211,000; Full time

Job summary

Stryker's Instruments Division is seeking a Principal Regulatory Affairs Specialist in a hybrid role near Portage, MI. You will be a key regulatory expert driving strategy across the product lifecycle, partnering with BD, Quality, Clinical, and Regulatory leaders to assess risks and guide decisions.

You will lead regulatory strategy for development, commercialization, and lifecycle activities, while supporting integration after acquisitions and advising project teams on compliance and standards.

Qualifications

• Minimum 8 years of relevant Regulatory Affairs/Quality Assurance experience within an FDA-regulated industry.
• Applied knowledge of FDA regulations and regulatory compliance requirements.

Responsibilities

• Partner with Business Development teams to support regulatory and quality due diligence activities for potential acquisitions.
• Conduct research and analysis of new technologies, business models, product portfolios, and regulatory landscapes to support strategic decision-making.
• Lead regulatory strategy development and execution for product development, commercialization, and lifecycle management activities.
• Collaborate with cross-functional partners to support integration planning and ensure key regulatory and quality considerations are appropriately addressed following acquisitions.
• Serve as a regulatory subject matter expert on significant projects, providing guidance on applicable regulations, standards, and compliance requirements.
• Monitor global regulatory changes and communicate impacts, risks, and required actions to project teams and stakeholders.
• Evaluate regulatory risks and develop mitigation strategies to support business and regulatory objectives.
• Review project progress, assess regulatory deliverables, and recommend procedural improvements to enhance compliance and efficiency.
• Collaborate with cross-functional teams to translate complex regulatory requirements into actionable project plans and compliance activities.

Skills

Regulatory expertise

Quality Assurance

Stakeholder influence

Ambiguity navigation

Regulatory strategy

Education

Bachelor's degree in Engineering or Biological Sciences

Regulatory Affairs Certification (RAC)

Master's degree in Regulatory Affairs or related discipline

Job description

Stryker's Instruments Division is seeking a Principal Regulatory Affairs Specialist in a hybrid role near Portage, MI. You will be a key regulatory expert driving strategy across the product lifecycle, partnering with BD, Quality, Clinical, and Regulatory leaders to assess risks and guide decisions.

You will lead regulatory strategy for development, commercialization, and lifecycle activities, while supporting integration after acquisitions and advising project teams on compliance and standards.