Collabera

Day To Day

Collabera is seeking a Sr. Global Recall Specialist to join the team immediately to support team by managing the initiation, execution, and closure of global recalls and field service notifications. This includes coordinating with cross-functional teams (QA, RA, Legal, and Supply Chain), maintaining audit-ready documentation, and ensuring all activities meet regulatory and internal QMS requirements. In addition to managing daily recall tasks, this person will play a key role in simplifying and modernizing existing recall processes as they transition to a new WindChill system, bringing best practices and driving efficiency, transparency, and faster execution timelines.

Must Haves

• 5+ years of experience in Quality Assurance or Regulatory Affairs within a medical device or other regulated industry, with direct involvement in recall or field action management
• Hands-on experience leading or supporting field service notifications, requalifications, and voluntary withdrawals, including end-to-end documentation and closure
• Strong working knowledge of FDA 21 CFR Parts 7 & 806 and ISO 13485 standards
• Proven ability to streamline or improve recall/field action processes - ideally within complex or outdated systems (e.g., WindChill, ERP)
• Excellent organizational, follow-up, and documentation skills, with the ability to work independently and manage multiple priorities in a fast-paced, compliance-driven environment

Plusses

• Experience supporting or implementing WindChill version upgrades or similar recall management systems
• Background in process improvement or procedure writing related to Quality Systems or recall operations
• Regulatory or Quality certifications (e.g., RAC, ASQ CQA, ISO 13485 Lead Auditor)
• Experience working in a global recall or field action environment with international regulatory exposure
• Prior experience in a medical device manufacturing or post-market quality function

Benefits

The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, (paid time , paid sick and safe time , hours of paid vacation time, weeks of paid parental leave, paid holidays annually - AS Applicable)