Staff Specialist, Regulatory Affairs

Work Flexibility: 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

• Bachelors 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

• Masters 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)

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.