Principal Regulatory Affairs Specialist, (Hybrid)

Stryker; Portage (MI); Híbrido; USD 127.000 - 211.000; Jornada completa

Descripción de la vacante

Stryker, Portage, MI, is seeking a Principal Regulatory Affairs Specialist to guide regulatory strategy across the product lifecycle. This role partners with Business Development, Quality, Clinical, and Regulatory leaders to assess risks and drive due diligence for acquisitions and partnerships.

The position emphasizes strategic initiatives, executive exposure, and cross-functional collaboration while leveraging deep regulatory expertise.

Formación

• Bachelor's degree required; Engineering or Biological Sciences preferred.
• Minimum 8 years of regulatory affairs/quality assurance experience in 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.
• Experience in medical device industry and lifecycle management.

Responsabilidades

• Partner with Business Development to support regulatory and quality due diligence for acquisitions.
• Lead regulatory strategy development and execution for product development, commercialization, and lifecycle management.
• Collaborate to support integration planning and address regulatory/quality considerations after acquisitions.
• Monitor global regulatory changes and communicate impacts to project teams and stakeholders.
• Translate complex regulatory requirements into actionable project plans and compliance activities.

Conocimientos

Regulatory compliance

FDA regulations

Regulatory strategy

Stakeholder influence

Educación

Bachelor's degree

Engineering or Biological Sciences preferred

Descripción del empleo

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

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