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Abbott · 5 months ago

Regulatory Affairs Specialist II – Electrophysiology (on-site)

Plymouth, MN

Full-time

Onsite

Entry, Mid Level

$61K/yr - $123K/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 and experienced Regulatory Affairs Specialist II to perform specialized work assignments and ensure compliance with regulatory agency specifications for Electrophysiology devices.

BiotechnologyEmergency MedicineGeneticsHealth CareHealth DiagnosticsManufacturingMedicalMedical DeviceNutritionPharmaceutical

Responsibilities

Preparation of regulatory submissions for Electrophysiology devices to achieve departmental and organizational objectives

Review and approve engineering change orders for protocols, reports, specifications, and other project related documentation supporting both new product development projects and sustaining activities

Acts as a regulatory representative responsible for review and analysis of applicable regulatory guidelines

Reviews and evaluates communications to ensure communications convey all necessary detail and adhere to applicable regulatory standards including those set by the FDA or other worldwide regulatory agencies to various international affiliates

Maintains 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, if requested

Supports the product release process by collaborating with the Regulatory Operations team and ensuring products are released in a compliant and timely manner to support Abbott customers

May interface directly with FDA and other regulatory agencies if so directed

Support all Company initiatives as identified by 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) regulations, international regulations and 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

Performs other related duties and responsibilities as assigned

Qualification

Regulatory AffairsMedical Device RegulationsRegulatory SubmissionsCommunication SkillsTeam Collaboration

Required

Bachelor's degree (or equivalent)

2-3 years' experience in a regulated industry (e.g., medical products, nutritionals). Regulatory area is preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area. Note : Higher education may compensate for years of experience

Ability to work within a team environment and accomplish projects within a fast-paced, matrixed environment

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