Regulatory Strategy Lead for M&A & Lifecycle

Stryker Corporation; Portage (MI); Hybride; USD 127 000 - 211 000; Plein temps

Avantages offerts par ce poste

Hybrid work model

Résumé du poste

Stryker Corporation is seeking a Principal Regulatory Affairs Specialist in the Instruments Division to guide regulatory strategy across the product lifecycle. You will work with Business Development, Quality, Clinical, and Regulatory leaders to assess risks, support acquisitions, and drive informed decisions.

The role requires deep regulatory expertise, collaboration with senior stakeholders, and the ability to navigate complex regulatory landscapes.

Qualifications

• Bachelor's degree required; engineering or biological sciences preferred.
• Minimum 8 years in Regulatory Affairs/Quality Assurance 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.
• Medical device industry experience strongly preferred.
• Experience supporting products through full lifecycle and BD/M&A activities.

Responsabilités

• Partner with Business Development to support regulatory and quality due diligence for acquisitions.
• Conduct research and analysis of new technologies, portfolios, and regulatory landscapes for strategy decisions.
• Lead regulatory strategy development for product development, commercialization, and lifecycle management.
• Collaborate with cross-functional teams to support integration planning post-acquisitions.
• Serve as regulatory subject‑matter expert on major projects; advise on regulations and compliance.
• Monitor regulatory changes and inform teams of impacts and required actions.
• Assess regulatory risks and develop mitigation strategies to support objectives.
• Translate complex regulatory requirements into actionable project plans and compliance activities.

Connaissances

Regulatory compliance knowledge

Stakeholder influence

Risk assessment

Regulatory strategy

Due diligence support

Formation

Bachelor's degree in Engineering or Biological Sciences

Master's degree in Regulatory Affairs or related field

Outils

RAC

Description du poste

Stryker Corporation is seeking a Principal Regulatory Affairs Specialist in the Instruments Division to guide regulatory strategy across the product lifecycle. You will work with Business Development, Quality, Clinical, and Regulatory leaders to assess risks, support acquisitions, and drive informed decisions.

The role requires deep regulatory expertise, collaboration with senior stakeholders, and the ability to navigate complex regulatory landscapes.