Principal Regulatory Affairs Specialist, (Hybrid)

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

Join Stryker's Instruments Division as a Principal Regulatory Affairs Specialist, where you will serve as a key regulatory expert supporting strategic business development and regulatory activities across the product lifecycle. In this highly visible role, you will partner closely with Business Development, Quality, Clinical, and Regulatory leaders to evaluate regulatory and quality risks, support due diligence activities related to acquisitions and partnerships, and help drive informed business decisions. This role offers unique exposure to strategic initiatives, executive stakeholders, and cross-functional collaboration while leveraging your deep regulatory expertise.

This unique position offers exposure across multiple functions, providing a career development opportunity beyond a traditional Regulatory Affairs role.

Work Flexibly: This is a hybrid role requiring a commutable distance to Portage, MI.

What You Will Do

• 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.

What You Will Need

Required 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.

Preferred Qualifications

• Regulatory Affairs Certification (RAC).
• Master's degree in Regulatory Affairs or related discipline.
• Medical device industry experience is 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.
• Demonstrated ability to assess regulatory and quality risks, navigate ambiguity, and influence stakeholders across complex organizations.

USN: $126,500 - $210,700 USD Annual

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.