Staff Regulatory Affairs Specialist

Work Flexibility: Hybrid

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:

• Bachelors 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 Masters 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: $114800 - $191400 USD Annual

View the U.S. work location and transparency guide to find the pay range for your location.

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 contractors legal duty to furnish information.