Senior Regulatory Affairs Specialist - Medical Devices

Regulatory Jobs; Portage (MI); Híbrido; USD 83.000 - 139.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Hybrid work arrangement

Descripción de la vacante

Stryker is hiring a Senior Regulatory Affairs Specialist for our Instruments/Neurosurgical division. This hybrid role requires two to three days onsite per week in Portage, MI, with hybrid work flexibility.

You will develop regulatory strategies, prepare submissions, assess regulatory impact of product changes, and support post-market activities. Collaboration with Product Development, Quality, Marketing, and regulators will be essential to ensure lifecycle compliance across markets.

Formación

• Bachelor’s degree in Engineering, Science, Life Sciences, or related discipline.
• Minimum 2 years in Regulatory Affairs or related discipline within a regulated industry.
• Experience preparing or coordinating regulatory submissions and related documentation.
• Experience applying regulatory requirements to development, commercialization, or post-market activities.

Responsabilidades

• Develop and implement regulatory strategies and submission plans.
• Prepare and submit regulatory documentation (registrations, listings, dossiers).
• Evaluate changes for regulatory impact across product lifecycle.
• Maintain post-market regulatory compliance and safety reporting.
• Review labeling, advertising, and promotional materials for compliance.
• Monitor regulatory intelligence and inform strategy for multiple markets.
• Collaborate with Product Development, Quality, Marketing and other stakeholders.
• Support regulatory inspections and train stakeholders on new requirements.

Conocimientos

Regulatory submissions

Regulatory strategy

Cross-functional collaboration

Regulatory compliance

Educación

Bachelor’s degree in Engineering, Science, Life Sciences, or related discipline

Descripción del empleo

Stryker is hiring a Senior Regulatory Affairs Specialist for our Instruments/Neurosurgical division. This hybrid role requires two to three days onsite per week in Portage, MI, with hybrid work flexibility.

You will develop regulatory strategies, prepare submissions, assess regulatory impact of product changes, and support post-market activities. Collaboration with Product Development, Quality, Marketing, and regulators will be essential to ensure lifecycle compliance across markets.