Regulatory Affairs Operations Specialist – Vascular (on-site)

Abbott • Temecula, CA

29d • $61,300 - $122,700 • Onsite

About The Position

This is a unique role where you will partner with external and internal stakeholders to maintain the quality system current and effective in alignment with the dynamic regulatory landscape and new/evolving requirements. The position is within the Regulatory Affairs Operations organization rather than direct regulatory submission preparation; this role involves supporting Quality System and Compliance initiatives such as Audit Readiness Program Management, including coordination of audit requests, Emerging Regulatory Issues and implementation of conformance, needs involving multiple therapies or device families, Quality System processes, Change Management, CAPAs, International Addendum Labeling controls, Management Review Metrics, etc.

Requirements

• Bachelor’s degree (or equivalent) in scientific discipline, engineering, or medical fields
• 2-3 years’ experience in a regulated industry (e.g., medical products, nutritionals, pharmaceuticals). Regulatory area is preferred but may consider quality assurance, research and development/support, scientific affairs, operations, regulatory compliance, 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.

Nice To Haves

• Bachelor’s degree in science (biology, chemistry, microbiology, etc.), math, engineering, or medical fields.
• 4+ years of related regulatory submission experience from medical device, pharmaceutical, or healthcare industry.
• Advanced level degree.
• Regulatory Operations, or Quality Systems, Regulatory Compliance experience; Class II or Class III medical device knowledge/ experience.
• Experience of working within the requirements of 21 CFR 820, ISO 13485, the EU Medical Device Regulations (EU MDR 2017/745), Medical Devices Directive (93/42/EEC)
• Previous experience working in a highly matrixed and geographically diverse business environment.

Responsibilities

• Assess and communicate impacts of evolving new regulations on internal quality system processes, regulatory submissions, and regulatory operational practices; ensures that information of such regulations and requirements, especially those that are new or modified, are distributed to appropriate personnel.
• Serve as a subject matter expert for International Addendum Labeling requirements and controls, partnering with Shared Services, International Regulatory Affairs, Labeling, Commercial Quality, and Regulatory Affairs to ensure requirements are reflected within the quality system, and business compliance with country-specific requirements.
• Manage execution of the Audit Readiness Program for Regulatory Affairs including preparation of pre-audit requests and in-audit requests, audit resource management, audit calendar and KPI management, and audit risk mitigation activities such as audit near misses / opportunities to closure, audit storyboards for critical topics; partner with Regulatory Compliance, Regulatory Affairs, Quality, Shared Services as needed for audits.
• Maintain key pre-audit requests up to date throughout the year and ensure that key audit activities are disseminated to appropriate personnel.
• Support audit backrooms, or front rooms as applicable.
• Prepare and / or review Regulatory Affairs formal management review and internal metrics content.
• Maintain processes and SOPs current, in alignment with new regulatory requirements. Creates, reviews, and processes, including approving change orders in the applicable document control systems.
• Assist in the development of quality system conformance strategy and update strategy based upon Emerging Issues/ Regulatory Intelligence.
• Acts as a regulatory operations representative on cross-functional project teams and task forces, communicates regulatory requirements and impact of regulations to the functional team(s). Provides guidance and expertise.
• Investigate nonconformities and determine mitigations, resolution plan (CAPA)
• Delivers on project timelines to achieve departmental and organizational objectives.
• 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.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level