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Boston Scientific · 3 hours ago

Senior Regulatory Specialist

Arbor Lakes, MN

Full-time

Hybrid

Mid, Senior Level

$83K/yr - $157K/yr

5+ years exp

Boston Scientific is a leader in medical science, dedicated to solving significant health industry challenges. The Senior Regulatory Specialist will be responsible for providing Regulatory Affairs support during the product development process, ensuring compliance and preparing regulatory submissions.

Health CareMedicalMedical Device

No H1B

Responsibilities

Begins to act as a company representative, developing and maintaining positive relationships with device reviewers through oral and written communications regarding pre-submissions strategy/regulatory pathway development testing requirements, clarification and follow-up of submissions under review

Assists with departmental policy and procedure implementation

Assists with Regulatory Affairs training to cross functional groups

Implements regulatory strategies for new and modified medical devices

Acts as a core member on manufacturing and development teams, providing Regulatory Affairs feedback and guidance throughout the product development cycle

Responsible for preparation and submission of regulatory applications, as well as internal regulatory file documentation

Reviews device labeling and advertising materials for compliance with global submissions and applicable regulations; analyzes and recommends appropriate changes

Reviews and signs-off on product and manufacturing changes for compliance with applicable regulations

Qualification

Regulatory AffairsMedical Device ComplianceProduct DevelopmentRegulatory SubmissionsCommunication Skills

Required

Minimum of 5 years of experience with a university degree or the equivalent combination of education and experience required; advanced/graduate degree preferred for some disciplines