Compliance Specialist 2

Location: Sunnyvale, CA 94043
Duration: 4+ Months

About the role

The primary function of this position is to coordinate and assist field action team related activities. The specialist will work closely with the field action team to ensure appropriate processing of customer acknowledgement forms and inquiries related to field actions. They will collaborate with business partners, the field action team, and management to address customer escalation concerns as they relate to field actions. The role requires strong organization and communication skills to support established customer-focused quality initiatives, as well as assisting the team in record retention based on company and regulatory standards.

Responsibilities

• Process and reconcile customer returned acknowledgement forms per regulations and internal procedures.
• Provide guidance to customers for product recall related questions.
• Help provide updates on effectiveness levels for each field action.
• Assist in preparing monthly regulatory reports on field action effectiveness status.
• Manage the recalls inbox and complete requests as needed.
• Assist in providing status updates to cross-functional teams when needed.
• Provide information to Audit Management on maintaining audit readiness for internal and external audits.
• Perform assessments, develop action plans, and drive execution to effectively manage the recall inbox and address urgent communications appropriately.
• Collaborate in the development, maintenance, and improvement of processes and procedures within the quality management system.

Requirements

• Minimum Bachelor’s degree—BS in Engineering, Physical or Biological Science, or other technical field.
• Minimum 4+ years’ experience in product quality or regulatory compliance (or combined experience) in the medical device or other regulated industry.
• General understanding of applicable US medical device regulations (e.g., 21 CFR Part 820, 21 CFR Part 11), international standards (e.g., ISO 13485, ISO 14971), and international regulations (e.g., CMDR - Canada, European, RDC - Brazil).
• Experience with computer regulations/standards and methodologies.
• Strong organizational, written, and verbal communication skills; critical thinking and proficiency in constructive dialogue.
• Effective at prioritizing tasks and responsibilities within a fast-paced, dynamic environment.
• Ability to collaborate and partner with the field action team while displaying an appropriate level of assertiveness.
• Experience working directly with the FDA, Notified Body, or other governmental agencies (preferred).

Benefits

• Competitive compensation.
• Comprehensive benefits, including medical, dental, vision, and retirement options.