Regulatory Affairs Specialist I

Boston Scientific•Maple Grove, MN

1d•$59,900 - $113,800•Hybrid

About The Position

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.

Requirements

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.

Nice To Haves

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.

Responsibilities

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.