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Abbott · 6 hours ago

Senior Regulatory Affairs Specialist - Electrophysiology (on-site)

Plymouth, MN

Full-time

Onsite

Mid, Senior Level

$75K/yr - $151K/yr

2+ years exp

Abbott is a global healthcare leader that helps people live more fully at all stages of life. They are seeking a passionate, experienced Senior Regulatory Affairs Specialist to lead the preparation and submission for regulatory approvals and provide regulatory guidance to cross-functional partners in support of various programs.

BiotechnologyEmergency MedicineGeneticsHealth CareHealth DiagnosticsManufacturingMedicalMedical DeviceNutritionPharmaceutical

Responsibilities

Prepares robust regulatory applications to achieve departmental and organizational objectives

Acts as a regulatory representative on core product development teams, communicates regulatory requirements and impact of regulations to the development team

Provides guidance and expertise on complex worldwide strategies with the help of international regulatory affiliates

Compile, prepare, review and submit medical device submissions to regulatory agencies

Interfaces directly with FDA and other regulatory agencies

Acts as liaison between the Company and the various appropriate regulatory agencies, ensuring that communications on both sides are germane, specific and convey all necessary detail

Maintains ongoing surveillance and analysis of all pertinent domestic and international medical device regulations to ensure submission requirements world-wide are current, up-to-date and are entered into regulatory submission data base and file systems. Ensures that information of such regulations and requirements, especially those that are new or modified, are distributed to appropriate personnel

Reviews device labeling for compliance with FDA submissions and applicable regulations

Supports the product release process by creating GTS licenses or reviewing and approving requests for product release

Conducts reviews of product and manufacturing changes for compliance with applicable commercial and clinical regulations

Supports all business segment initiatives as identified by divisional management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements

Complies with U.S. Food and Drug Administration (FDA) and international regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors

Provides mentoring and leadership to other Regulatory team members

Qualification

Regulatory submission experienceMedical device regulationsFDA complianceRisk managementDesign verificationProcess validationMS Office proficiencyCommunication skillsTeam leadershipCross-functional collaboration

Required

Bachelor's Degree; preferably in a technical discipline such as biology, chemistry, microbiology, immunology, medical technology, etc

Minimum 2 yrs. regulatory experience and or 2 years relevant industrial experience typically with a quality; product-development/support; scientific affairs function

Preferred

4+ years of related regulatory submission experience from medical device, pharmaceutical, or healthcare industry

Advanced level degree

Class II or Class III medical device experience

Experience with PMA supplements, 510(k) applications, and US device regulations and/or experience with EU and other international medical device regulations and submissions

Experience with risk management, design verification, or process validation work

Proficient with MS Office suite (Word, Excel, Outlook)

Previous experience working in a highly matrixed and geographically diverse business environment

Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization

Benefits

Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year

An excellent retirement savings plan with high employer contribution

Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.