Principal Regulatory Affairs Specialist

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

Work Flexibility: Hybrid

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.

Travel Percentage: 20%Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.