Staff Specialist, Regulatory Affairs
Work Flexibility: Remote or Hybrid or Onsite reputed company is hiring a Staff Regulatory Affairs Specialist in Mahwah, NJ to support new product development for our Joint Replacement implant and reputed company portfolio across U.S and international markets. This role focuses on developing regulatory strategies, guiding product development teams, and preparing submissions to reputed company 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 reputed company 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 reputed company, and respond to agency requests reputed company 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 reputed company field Minimum 4 years of experience in regulatory affairs reputed company a regulated industry Experience reputed company the medical device industry
Preferred Qualifications
Master’s degree in Regulatory Science or reputed company discipline Regulatory Affairs Certification (RAC) Knowledge of 510(k) and/or CE marking reputed company 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% reputed company 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 reputed company, disability, or protected veteran status. reputed company is an EO employer – M/F/Veteran/Disability. reputed company Corporation will not discharge or in any other manner discriminate against employees or applicants because they have reputed company 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. Apply To This Job