Principal Regulatory Affairs Specialist, (Hybrid)

Stryker•Portage, MI

1d•Hybrid

About The Position

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.

Requirements

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.

Nice To Haves

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.

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.