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Teleflex · 23 hours ago

Senior Regulatory Affairs Specialist

Maple Grove 6401 MN USA

Full-time

Onsite

Senior Level

$109K/yr - $164K/yr

5+ years exp

Teleflex is a global provider of medical technologies focused on improving health and quality of life. The Senior Regulatory Affairs Specialist will develop regulatory strategies and submissions for complex projects across multiple business units and mentor Regulatory Specialists as part of the role.

CommercialHealth CareMedicalMedical Device

Responsibilities

Conduct appropriate research using standards, guidance documents, previous assessments and other resources to develop strong regulatory assessments for the US, EU and Canada for new and modified products

Assume full responsibility for project submissions for 510(k) premarket notifications, EU MDD Technical File/MDR Technical Documentation, and Canadian license submission/amendments

Communicate with Commercial RA to ensure timely notification of changes as appropriate. Partner with Commercial RA to support registration of product in foreign markets

Work with Quality, Operations, Engineering, and other internal groups to investigate and recommend solutions to address potential regulatory issues and impacts

Interact and negotiate with regulatory authorities during the development (i.e. Q-Sub, change notifications, etc.) and submission review

Support regulatory agency and/or notified body audits by as needed

Participate in and ensure compliance with design controls and review design documentation to confirm regulatory requirements are met

Participate in development and approval of risk activities as well as other deliverables as related to projects

Provide regulatory review for reporting activities required by EU MDR (i.e. post-market surveillance, reporting, etc.)

Review and approve all Labeling (product, advertising and promotional) and ensure claims are substantiated

Assist in regulatory due diligence process as needed

Proactively drive RA project deliverables by collaborating cross-functionally and engaging with cross-business unit team members as needed

Monitor impact of changing evolving global regulations on submissions, practices and procedures and communicate to internal stakeholders

Brings Regulatory Affairs questions/issues to the attention of RA management

Comply with Teleflex’s Code of Ethics, all Company policies, rules, and procedures

Qualification

Medical Device Regulatory AffairsRegulatory SubmissionsRisk ManagementRAC CertificationMS Office ProficiencyAnalytical SkillsCommunication SkillsTeam CollaborationProject Management