at Stryker
Location
Mahwah, New Jersey
Compensation
$115k–$191k USD
Posted
1 weeks ago
Market range · function + seniority
p25 · target · p75 · n=175
Posted $191k · in the market band
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Stryker is hiring a Staff Regulatory Affairs Specialist in Mahwah, NJ to ensure continued market access and regulatory compliance for its Joint Replacement implant and instrument portfolio across U.S. and international markets. This role focuses on maintaining compliance for marketed products, evaluating regulatory changes, and supporting product lifecycle activities. You will work across functions and geographies to ensure submissions, labeling, and processes align with current regulatory requirements.
What You Will Do
Maintain regulatory compliance for marketed medical devices across U.S. and international markets
Monitor and evaluate changes in global medical device regulations, with a strong focus on EU MDR, and implement required updates to maintain market access
Prepare and submit regulatory submissions in alignment with regional and global requirements
Assess the regulatory impact of product, process, or labeling changes and support required notifications or submissions
Review product labeling and promotional materials to ensure alignment with regulatory standards
Develop and update standard operating procedures and implement process improvements to support regulatory compliance
Provide regulatory guidance to internal stakeholders and deliver training on current and evolving requirements
Partner with global affiliates to support product registrations and maintain accurate regulatory documentation
What You Will Need
Required Qualifications:
Bachelor’s degree required; strongly preferred in Engineering, Science, or a related technical field
4+ years of experience in an FDA-regulated environment, specifically within medical devices or pharmaceutical industries
Preferred Qualifications:
RAC certification or Master’s degree in Regulatory Affairs or related field
Experience supporting Class II and/or Class III medical device products
Experience preparing regulatory submissions (e.g., 510(k), technical files)
Knowledge of medical device product development and design control processes
Ability to proactively communicate, escalate risks appropriately, and engage leadership when needed
US20: $114,800 - $191,400 USD Annual
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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.
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