Senior Specialist, Regulatory Affairs

Stryker · Portage, MI

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RegulatoryFull-time$83k–$139kCompany career page

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What they're looking for

Bachelor's degree in Regulatory Affairs, Engineering, Life Sciences, or related field
Minimum 2 years regulatory affairs experience in medical device, biotech, pharma, or regulated industries
Knowledge of global regulatory requirements and compliance assessment
Experience with regulatory documentation, procedures, and submission requirements
Preferred: Regulatory Affairs Certification (RAC)
Preferred: Environmental regulations compliance and reporting experience
Preferred: Master's degree in Regulatory Affairs or related discipline

What you'll be doing

Develop, review, and maintain regulatory procedures, documentation, and compliance strategies
Assess global regulatory and environmental impacts on products, processes, and business activities
Provide regulatory input for product development, lifecycle management, and modifications
Research regulatory pathways, product classifications, and identify approval challenges and risks
Support preparation of regulatory deliverables and define submission and registration requirements

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