Senior Regulatory Affairs Specialist (Hybrid)

Stryker; Portage (MI); Hybride; USD 83 000 - 139 000; Plein temps

Résumé du poste

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

You will develop and implement regulatory strategies, prepare and submit registrations and related documents, and evaluate changes for regulatory impact across the product lifecycle while ensuring post-market compliance.

Qualifications

• Bachelor’s degree in a related discipline is required.
• 2+ years of experience in Regulatory Affairs or a related regulatory discipline within a regulated industry.
• Experience preparing, coordinating, or executing regulatory submissions and related documentation.

Responsabilités

• Develop and implement regulatory strategies and submission plans based on product classification, market requirements, approval pathways, and applicable regulations.
• Prepare and submit regulatory documentation, including product registrations, annual licenses, listings, supplemental dossiers, and notifiable changes to applicable regulatory authorities.
• Evaluate product and manufacturing changes for regulatory impact and recommend submission, approval, and compliance requirements throughout the product lifecycle.
• Maintain post-market regulatory compliance by supporting safety reporting, product recalls, post-market commitments, required reports, and communications with regulatory authorities.
• Review advertising, promotional materials, product labeling, and instructions for use to verify alignment with applicable regulatory requirements.
• Monitor regulatory intelligence and assess emerging requirements, risks, and market access considerations to inform local, regional, and global regulatory strategies.
• Partner with Product Development, Quality, Marketing, and other stakeholders to integrate regulatory requirements into product development, commercialization, and lifecycle activities.
• Support regulatory inspections and audits, develop regulatory procedures and standard operating procedures, and train stakeholders on new or changing regulatory requirements.

Connaissances

Regulatory affairs

Regulatory submissions

Product lifecycle

Regulatory compliance

Formation

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

Master's degree in Regulatory Science or RAC

Description du poste

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

What You Will Do

• Develop and implement regulatory strategies and submission plans based on product classification, market requirements, approval pathways, and applicable regulations.
• Prepare and submit regulatory documentation, including product registrations, annual licenses, listings, supplemental dossiers, and notifiable changes to applicable regulatory authorities.
• Evaluate product and manufacturing changes for regulatory impact and recommend submission, approval, and compliance requirements throughout the product lifecycle.
• Maintain post-market regulatory compliance by supporting safety reporting, product recalls, post-market commitments, required reports, and communications with regulatory authorities.
• Review advertising, promotional materials, product labeling, and instructions for use to verify alignment with applicable regulatory requirements.
• Monitor regulatory intelligence and assess emerging requirements, risks, and market access considerations to inform local, regional, and global regulatory strategies.
• Partner with Product Development, Quality, Marketing, and other stakeholders to integrate regulatory requirements into product development, commercialization, and lifecycle activities.
• Support regulatory inspections and audits, develop regulatory procedures and standard operating procedures, and train stakeholders on new or changing regulatory requirements.

What You Need

Required

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

Preferred

• Master's degree in Regulatory Science or Regulatory Affairs Certification (RAC)
• Experience in the medical device industry
• Experience supporting product registrations, regulatory submissions, product changes, or post-market regulatory activities across multiple markets
• Experience interacting with regulatory authorities or supporting regulatory inspections and audits

• USN: $83,300 - $138,800 USD Annual