Senior Regulatory Affairs Specialist

Regulatory Toolkit; Portage (MI); Hybrid; USD 83,000 - 139,000; Full time

Benefits offered by this job

Hybrid work arrangement

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Regulatory submissions

Regulatory strategy

Cross-functional collaboration

Regulatory compliance

Education

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

Job description

Work Flexibility: Hybrid

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

Travel Percentage: 10%

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M/F/Veteran/Disability.Stryker Corporation will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor’s legal duty to furnish information.