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Job Title:

Senior Recall Specialist Shift:

M-F 1st Shift (hours, TBD)

Notes:

100% onsite, cannot be remote Looking for experience in these industries: Medical Device, Pharmaceuticals, Biotechnology, Diagnostics, Aerospace Key skills: FDA recalls, Field Actions, CAPA, Medical Device Reporting (MDR), FDA 21 CFR Part 820 (or the updated Quality Management System Regulation), ISO 13485, Complaint investigations, Risk assessments, Health Hazard Evaluations (HHE), Regulatory submissions & Quality Management Systems (QMS) This is a senior Quality/Regulatory Affairs professional responsible for ensuring that company manages medical device recalls and field actions in compliance with FDA and international regulatory requirements. Candidates with prior medical device recall, field action, CAPA, complaint handling, or regulatory affairs experience will be the strongest fit.

Summary:

Are you a quality-focused professional with a passion for ensuring product safety and compliance in the medical device industry? We are seeking a dynamic Sr. Recall Specialist to oversee the preparation and execution of Field Actions. Based in Newark, DE, this pivotal role requires onsite presence and offers the opportunity to make a significant impact on global recall strategies and regulatory communications.

Field Action Management :

Support the management and coordination of the preparation and execution of field actions globally. Participate in cross-functional meetings to develop plans and deliverables for various activities supporting Field Actions.

Global Recall Strategies :

Collaborate with divisional stakeholders to develop comprehensive global recall strategies and regulatory communications. Coordinate with international QA/RA representatives to tailor regional recall strategies and regulatory communications.

Health Risk and Hazard Evaluations :

Develop Health Risk Assessments, Health Hazard Evaluations, and Remedial Action Assessments. Work closely with Quality on processing Field Action records in Agile.

Customer and Regulatory Communications :

Partner with Marketing, Legal, R&D, Quality, and Regulatory teams to develop customer communications and field personnel FAQs. Support communications and meetings with regulatory bodies, Notified Bodies, and competent authorities regarding field actions.

Tracking and Documentation :

Track the effectiveness of field actions, including reconciliation of communications, corrections, and/or removals. Reconciliation, quarantine, and destruction of returned product Maintain and attach supporting records and documentation to Field Action records.

Process Development and Training :

Feed into the Field Action process and supporting work instructions Qualifications (Education & Experience):

Preferred Minimum Technical Degree:

BA/BS Degree 5 Plus years of experience in quality assurance, regulatory affairs, or supply chain management, particularly with FDA regulations or similar heavily regulated industry Experience with FDA's Industry Guidance for Recalls and guidance on distinguishing medical device recalls from enhancements. Familiarity with

MEDDEV 2.12/1

Guidance on Market Surveillance - Guidelines on Medical Devices Vigilance System. Skills Ability to assess written product and project documentation as the principal advocate for compliance and effectively communicate assessments. Demonstrates independent decision-making and prioritization, including resolving conflicts and taking leadership roles on critical tasks. #CNX200

Pay:

$85,000.00 - $125,000.00 per year

Benefits:

401(k) 401(k) matching Dental insurance Health insurance Life insurance Paid time off Vision insurance

Experience:

qa, reg affairs in med device, pharma, biotech or diagn.: 5 years (Required) FDA recalls,

Field Actions, CAPA, Medical Device Reporting:

5 years (Required) medical device recalls: 5 years (Required)

Work Location:

In person