Apply on Employer Site

Boston Scientific · 1 day ago

Regulatory Affairs Specialist II

Arbor Lakes, MN

Full-time

Hybrid

Entry, Mid Level

$70K/yr - $132K/yr

2+ years exp

Boston Scientific is a leader in medical science, dedicated to advancing science for life through innovative medical solutions. The Regulatory Affairs Specialist II will provide regulatory support for Peripheral Intervention devices, ensuring product compliance and navigating global regulatory requirements.

Health CareMedicalMedical Device

No H1B

Responsibilities

Supporting Regulatory Affairs activities related to peripheral vascular devices within the ICTx portfolio

Representing Regulatory Affairs on core project teams by providing guidance throughout product development and lifecycle management

Acting as a liaison with regulatory agencies through written and verbal communications, including submission strategy and pathway development

Preparing and submitting regulatory documentation to support global compliance and product approvals

Reviewing and approving product changes, labeling, and promotional materials to ensure regulatory compliance

Participating in internal initiatives to improve quality systems in alignment with Boston Scientific’s Quality Policy

Supporting department and divisional process improvements through collaboration, best practice sharing, and cross-functional engagement

Participating in regulatory audits/inspections by agencies such as the FDA, DEKRA, BSI, and HPRA

Qualification

Regulatory AffairsFDA regulationsEU regulationsMicrosoft OfficeTechnical writingInterpersonal skillsCollaborationSelf-starterProject management

Required

Minimum of a Bachelor's degree in Science, Engineering, or a related discipline

Minimum of 2 years' experience in Regulatory Affairs or related fields (e.g., Quality, Clinical, R&D) within the medical device industry

Proficiency in Microsoft Word, Excel, Teams, PowerPoint, and Adobe Acrobat

Working knowledge of FDA, EU, and international medical device regulations

Strong technical writing and editing abilities for regulatory documentation

Ability to interpret and apply regulatory guidelines and standards

Preferred

Excellent written and verbal communication skills

Strong interpersonal skills and a collaborative team mindset

Self-starter with the ability to work independently and adapt quickly in fast-paced environments

Proven ability to manage multiple projects and meet deadlines in a dynamic environment

Experience collaborating on cross-functional teams

Benefits

Compensation 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 may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements).