Staff Specialist, Regulatory Affairs
Work Flexibility: Remote or Hybrid or Onsite
Stryker is hiring a Staff Regulatory Affairs Specialist in Mahwah, NJ to support new product development for our Joint Replacement implant and instrument portfolio across U.S and international markets. This role focuses on developing regulatory strategies, guiding product development teams, and preparing submissions to achieve market access across U.S. and international markets.
What you will do
Assess regulatory intelligence and update local, regional, and global regulatory strategies based on evolving requirements
Evaluate the regulatory environment and provide guidance across product lifecycle phases including development, manufacturing, and commercialization
Determine product classification, submission requirements, and approval pathways across domestic and international markets
Prepare and submit regulatory filings in accordance with applicable global regulations and timelines
Identify regulatory risks and obstacles, propose mitigation strategies, and recommend refinements based on regulatory outcomes
Provide regulatory guidance on quality, preclinical, and clinical documentation to ensure submission readiness and compliance
Communicate with regulatory authorities to support submissions, monitor review progress, and respond to agency requests
Develop or update regulatory procedures and train cross-functional stakeholders to maintain compliance across the organization
What you will need
Required Qualifications
Bachelor’s degree required. Preferred to be in Engineering, Science, or a related field
Minimum 4 years of experience in regulatory affairs within a regulated industry
Experience within the medical device industry
Preferred Qualifications
Master’s degree in Regulatory Science or related discipline
Regulatory Affairs Certification (RAC)
Knowledge of 510(k) and/or CE marking pathways
Experience preparing and submitting regulatory filings (e.g., FDA, EU, or international submissions)
Experience supporting product lifecycle regulatory activities (development through post-market)
United States of America Pay Ranges:
Puerto Rico: $77,700 - $129,500 USD Annual
USN: $95,700 - $159,500 USD Annual
US5: $100,500 - $167,500 USD Annual
US10: $105,300 - $175,500 USD Annual
US15: $110,100 - $183,400 USD Annual
US20: $114,800 - $191,400 USD Annual
US30: $124,400 - $207,400 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 contractor’s legal duty to furnish information.
Stryker is hiring a Staff Regulatory Affairs Specialist in Mahwah, NJ to support new product development for our Joint Replacement implant and instrument portfolio across U.S and international markets. This role focuses on developing regulatory strategies, guiding product development teams, and preparing submissions to achieve market access across U.S. and international markets.
What you will do
Assess regulatory intelligence and update local, regional, and global regulatory strategies based on evolving requirements
Evaluate the regulatory environment and provide guidance across product lifecycle phases including development, manufacturing, and commercialization
Determine product classification, submission requirements, and approval pathways across domestic and international markets
Prepare and submit regulatory filings in accordance with applicable global regulations and timelines
Identify regulatory risks and obstacles, propose mitigation strategies, and recommend refinements based on regulatory outcomes
Provide regulatory guidance on quality, preclinical, and clinical documentation to ensure submission readiness and compliance
Communicate with regulatory authorities to support submissions, monitor review progress, and respond to agency requests
Develop or update regulatory procedures and train cross-functional stakeholders to maintain compliance across the organization
What you will need
Required Qualifications
Bachelor’s degree required. Preferred to be in Engineering, Science, or a related field
Minimum 4 years of experience in regulatory affairs within a regulated industry
Experience within the medical device industry
Preferred Qualifications
Master’s degree in Regulatory Science or related discipline
Regulatory Affairs Certification (RAC)
Knowledge of 510(k) and/or CE marking pathways
Experience preparing and submitting regulatory filings (e.g., FDA, EU, or international submissions)
Experience supporting product lifecycle regulatory activities (development through post-market)
United States of America Pay Ranges:
Puerto Rico: $77,700 - $129,500 USD Annual
USN: $95,700 - $159,500 USD Annual
US5: $100,500 - $167,500 USD Annual
US10: $105,300 - $175,500 USD Annual
US15: $110,100 - $183,400 USD Annual
US20: $114,800 - $191,400 USD Annual
US30: $124,400 - $207,400 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 contractor’s legal duty to furnish information.