Director of Produce Surveillance

Follow your aspirations to Abbott for diverse opportunities, competitive salaries, great benefits, a 401(k) retirement savings plan, a company paid pension plan and profit sharing, all with a company providing the growth and strength to build your future.
Provide Global oversight to complaint registration / investigation and adverse event reporting activities of locations in Galway and Redwood City.
o Ensure that practices are effectively harmonized and implemented throughout the division in a manner that is compliant with Abbott policies and all applicable laws and regulations.
o Review all adverse event reports for completeness, consistency and timeliness.
o Support routine FDA and other inspections at both FDU sites.
Ensure that global complaint and adverse event data is appropriately tracked and trended, and that the results of such analyses are effectively communicated to management for review.
Comply with ISO 14971 Risk Management Requirements for Postmarket Surveillance.
Serve as Chairperson of the AVD Complaint Risk Management Board (CRMB), which entails:
o Ensuring that divisional CRMB meetings are scheduled, conducted, and documented as required
o Ensuring that Health Hazard Assessments (HHA) are documented, reviewed, and approved in accordance with procedures, and that all remedial actions identified in HHAs (e.g., CAPA investigation, field action) are communicated to appropriate management personnel and effectively implemented
o Consulting with medical advisors as needed to facilitate the accurate assessment of medical risk associated with complaints and/or reportable adverse events related to AVD products
Ensure that information from Risk Management activities is communicated to other entities within AVD as appropriate (e.g., site CAPA Managers, Research & Development, Operations) to facilitate continuous improvement of AVD products, processes, and quality systems.
Interface with Medical personnel as needed for above.
Administer the Pilgrim SmartComplaint software module

Qualifications
Bachelor's degree

Thorough knowledge of medical device and pharmaceutical quality system and related regulations and standards (e.g., 21 CFR 211 & 820, ISO 13485, ISO 14971)
Exceptional written and verbal communication skills
Ability to work in team environment
Ability to effectively manage direct reports
Ability to conduct internet and literature-based research on a variety of regulatory issues
Detail-oriented
Thorough knowledge of medical device and pharmaceutical quality system and related regulations and standards (e.g., 21 CFR 211 & 820, ISO 13485, ISO 14971)
Exceptional written and verbal communication skills
Ability to work in team environment
Ability to effectively manage direct reports
Ability to conduct internet and literature-based research on a variety of regulatory issues
Detail-oriented
5 years of supervisory experience in a medical device or other FDA-regulated industry; Quality Assurance or Regulatory Affairs experience preferred.




Abbott welcomes and encourages diversity in our workforce. EEO/AA

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