Senior Regulatory Strategy Lead: M&A & Lifecycle

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

Job summary

Stryker's Instruments Division is seeking a Principal Regulatory Affairs Specialist to serve as a key regulatory expert supporting business development and regulatory activities across the product lifecycle. You will partner with Leadership across Quality, Clinical, Regulatory to evaluate regulatory risks and guide due diligence for acquisitions, driving informed business decisions.

This hybrid role offers exposure to executive stakeholders and strategic initiatives, spanning product

Qualifications

• 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.

Responsibilities

• Partner with Business Development to support regulatory and quality due diligence for acquisitions.
• Research regulatory landscapes, technologies, product portfolios, and regulatory landscapes to support strategic decisions.
• Lead regulatory strategy development for product development, commercialization, and lifecycle management activities.
• Collaborate with cross-functional partners to support integration planning and ensure regulatory and quality considerations are addressed after acquisitions.
• Serve as a regulatory subject matter expert on significant projects, guiding regulations, standards and compliance requirements.
• Monitor global regulatory changes and communicate impacts, risks, and actions to project teams and stakeholders.
• Evaluate regulatory risks and develop mitigation strategies to support objectives.
• Review project progress, assess regulatory deliverables, and propose procedural improvements to enhance compliance and efficiency.
• Translate complex regulatory requirements into actionable project plans and compliance activities.

Skills

Regulatory affairs expertise

Quality assurance

FDA regulations

Cross-functional collaboration

Stakeholder influence

Education

Bachelor’s degree in Engineering / Biological Sciences or equivalent

Master’s degree in Regulatory Affairs or related discipline

Job description

Stryker's Instruments Division is seeking a Principal Regulatory Affairs Specialist to serve as a key regulatory expert supporting business development and regulatory activities across the product lifecycle. You will partner with Leadership across Quality, Clinical, Regulatory to evaluate regulatory risks and guide due diligence for acquisitions, driving informed business decisions.

This hybrid role offers exposure to executive stakeholders and strategic initiatives, spanning product