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Teleflex · 1 day ago

Sr. Regulatory Affairs Specialist

Morrisville, NC

Full-time

Hybrid

Senior Level

$109K/yr - $120K/yr

5+ years exp

Teleflex is a global provider of medical technologies dedicated to improving health and quality of life. The Senior Regulatory Affairs Specialist will focus on supporting material cost improvement projects, developing strategies and regulatory submissions, and collaborating with various teams to ensure regulatory compliance and alignment with commercial objectives.

CommercialHealth CareMedicalMedical Device

Responsibilities

Provide Regulatory support and serve as the RA Lead in the team driving Material CIP program

Support new supplier/vendor changes

Identify key risks on Material CIP Program and communicate appropriately into the Project Lead to ensure all regulatory impacts are captured for each project

Support the Program Lead in developing RA timelines in line with project charters and implementation plans

Collaborate with the appropriate RA functional peers to establish key risks and develop program implementation plans

Manage Technical Documentation

Manage Global regulatory impact assessments

Review and assess change control activities for potential impact on current regulatory filings

Work with Program lead to estimate the resources and participants needed to achieve project goals

Proactively manage changes in project scope, identify potential risks, and devise contingency plans

Manage stakeholder communication to ensure project status and/or related issues are effectively communicated

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

Ensure all operations are fully compliant with license details and updated in accordance with relevant guidelines and directives

Interact and negotiate with regulatory authorities during the development and review process to ensure submission approval as well as during audits to mitigate any potential risks

Qualification

Regulatory AffairsMedical Device RegulationsTechnical WritingQuality AssuranceRisk ManagementProject ManagementProblem SolvingAttention to DetailCommunication SkillsTeam CollaborationAdaptability

Required

Bachelor Degree in Science or Engineering disciplines

Minimum 5+ years of experience working within medical device industry; 3+ years with Class II or higher registrations

Knowledge and understanding of US, EU and Canada medical device regulations, standards, and guidance documents

Quality Assurance (21 CFR 820, ISO 13485) and Risk Management (ISO 14971) experience required

Excellent technical writing experience within a medical device environment – essential

Attention to detail and accuracy – essential

Fluent in English, both written and oral – essential

Ability to work well under deadlines and pressure

Problem solving skills for developing creative solutions and meeting objectives are required

Skills that enable coordination of data, including MS-Office (primarily PowerPoint, Word, MD Project, Outlook and Excel)

Ability to prioritize tasks and manage several projects and tasks simultaneously; and to interface with all levels of management

Preferred

Experience with Corrective Action, Manufacturing and Design Control concepts desired

Computer literate (i.e., statistical software and analysis, excel, word processing for report generation, PowerPoint presentations, etc.)

Positive attitude and ability to operate and communicate effectively with multiple teams & leadership

Ability to reason, support and prioritize projects, adapt to shifting priorities, effectively solve problems / conflicts, and proactively effect change