Senior Regulatory Affairs Leader - M&A & Lifecycle Strategy

Regulatory Jobs; Portage (MI); Hybride; USD 127 000 - 211 000; Plein temps

Avantages offerts par ce poste

Hybrid work arrangement

Résumé du poste

Stryker Corporation in Portage, MI is seeking a Principal Regulatory Affairs Specialist to serve as a regulatory expert across the product lifecycle. You will partner with Business Development, Quality, Clinical, and Regulatory leaders to evaluate regulatory and quality risks and support due diligence for acquisitions and partnerships.

This highly visible role offers exposure to strategic initiatives and executive stakeholders, with hybrid work and cross-functional collaboration to translate

Qualifications

• Bachelor's degree required; engineering, biological sciences or related focus preferred.
• Minimum 8 years of Regulatory Affairs/QA experience in FDA-regulated industry.
• Applied knowledge of FDA regulations and regulatory compliance.

Responsabilités

• Partner with Business Development to support regulatory and quality due diligence for potential acquisitions.
• Research technologies, business models, product portfolios, and regulatory landscapes for strategic decisions.
• Lead regulatory strategy for development, commercialization, and lifecycle management.
• Collaborate on integration planning and ensure regulatory and quality considerations are addressed after acquisitions.
• Serve as regulatory SME on major projects and communicate regulatory changes and actions.
• Monitor global regulatory changes and advise project teams on impacts and actions.
• Evaluate regulatory risks and develop mitigation strategies to support objectives.
• Review progress and recommend improvements to compliance and efficiency.
• Translate regulatory requirements into actionable project plans and compliance activities.

Connaissances

Regulatory strategy

Due diligence

Cross-functional collaboration

Regulatory compliance

Risk assessment

Formation

Bachelor's degree

Description du poste

Stryker Corporation in Portage, MI is seeking a Principal Regulatory Affairs Specialist to serve as a regulatory expert across the product lifecycle. You will partner with Business Development, Quality, Clinical, and Regulatory leaders to evaluate regulatory and quality risks and support due diligence for acquisitions and partnerships.

This highly visible role offers exposure to strategic initiatives and executive stakeholders, with hybrid work and cross-functional collaboration to translate