Regulatory Affairs Specialist I

Additional Location(s): N/A Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance At Boston Scientific, we’ll give you the opportunity to harness all that’s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we’ll help you in advancing your skills and career. Here, you’ll be supported in progressing – whatever your ambitions. We will consider qualified applicants of all ages who are starting (or restarting) their careers At Boston Scientific, we value collaboration and synergy. This role follows a hybrid work model, requiring employees to be in our local office at least three days per week. Boston Scientific will not offer sponsorship or take over sponsorship of an employment VISA for this position at this time About the Role The Regulatory Affairs Specialist I supports product development, regulatory submissions, global registrations, and regulatory compliance activities throughout the medical device lifecycle. Working under the guidance of experienced regulatory professionals, this role partners with cross-functional teams to assist with regulatory strategy, prepare and maintain submission documentation, assess product and manufacturing changes, support continued market access, and promote quality and continuous improvement. Your Responsibilities Will Include Assist in developing and maintaining productive relationships with regulatory agency and notified body reviewers through clear oral and written communications regarding regulatory pathways, testing requirements, submission questions, clarifications, and follow-up activities. Assist in drafting and implementing regulatory strategies for new and modified medical devices to include Mechanical Circulatory Support systems. Support cross-functional development teams by providing regulatory feedback and guidance throughout the product development cycle. Coordinate and compile team inputs and supporting documentation for U.S., EU, and other global regulatory submissions. Assist with preparation, submission, and maintenance of regulatory applications and internal regulatory file documentation. Support international regulatory partners in obtaining and maintaining product registrations and approvals. Review device labeling and advertising materials for consistency with approved submissions and applicable regulatory requirements; analyze and recommend appropriate changes. Review product, design, manufacturing, supplier, and process changes to assess regulatory impact and support compliance with applicable requirements. Prepare and maintain change impact assessments and other regulatory records supporting continued compliance with regulatory agency approvals. Understand and support product lifecycle processes, including sustaining and regulatory approval maintenance activities. Demonstrate commitment to patient safety, product quality, the Quality Policy, and applicable quality system regulations through daily work practices. Required Qualifications Bachelor's degree in Genetics and Genomics. Must be eligible to work in the United States without company sponsorship, now or in the future, for employment-based work authorization. At least three months of experience in Regulatory Affairs. Prior internship experience with Boston Scientific. Familiarity with U.S. FDA, EU medical device, and international regulatory requirements. Experience supporting technical writing, document review, change assessment, or product development activities. Preferred Qualifications Master's degree in Biotechnology. Experience or coursework related to medical devices, biotechnology, engineering, quality, clinical research, or regulatory affairs. Strong written and verbal communication skills, including the ability to analyze, organize, and clearly present technical information. Ability to collaborate effectively on cross-functional teams and manage multiple assignments and priorities. Attention to detail and commitment to maintaining accurate, complete regulatory documentation. Minimum Salary: $ 59900 Maximum Salary: $ 113800 The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) – see vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above. Compensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements). Compensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements). For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability. Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 45 years, we advance science for life by providing a broad range of high-performance solutions that address unmet patient needs and reduce the cost of healthcare. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions. Learn more at and follow us on LinkedIn. Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class. Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company’s policies or protocols change with regard to COVID-19 vaccination. Among other requirements, Boston Scientific maintains specific prohibited substance test requirements for safety-sensitive positions. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law. #J-18808-Ljbffr