Additional Location(s): N/A
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.
Requisition ID: 633261Minimum 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 www.bscbenefitsconnect.com-will 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.
