Compliance Specialist (Hybrid - Sunnyvale, CA)

• Please note that our customer is currently not considering applicants from the following locations: Alabama, Arkansas, Delaware, Florida, Indiana, Iowa, Louisiana, Maryland, Mississippi, Missouri, Oklahoma, Pennsylvania, South Carolina, and Tennessee.***
  
  

Our Customer is a corporation that develops, manufactures, and markets robotic products designed to improve clinical outcomes of patients through minimally invasive surgery. Founded in 1995, their goal was to create innovative, robotic-assisted systems that help empower doctors and hospitals to make surgery less invasive than an open approach. Working with the top medical professionals, they continue to develop new, minimally invasive surgical platforms and future diagnostic tools to help solve complex healthcare challenges around the world.

We are seeking a Compliance Specialist on a contract basis to support our Customer's business needs. This role is hybrid (3 days on-site and 2 days remote/week) in Sunnyvale, CA.

The primary function of this position is to coordinate and assist field action team-related activities. They are to possess a general understanding of the field action process. They will work closely with the field action team to ensure that appropriate processing of customer acknowledgement forms and inquiries related to field actions. Collaboration with business partners, the field action team, and management to address customer escalation concerns as it relates to field action. They will have strong organization and communication skills to support established customer-focused quality initiatives. The specialist will also be expected to assist the team in record retention based on company and regulatory standards.

Responsibilities

• Process and reconcile customer return acknowledgment forms in accordance with regulations and internal procedures
• Provide guidance to customers regarding product recall inquiries
• Track and report effectiveness metrics for field actions
• Assist in preparing monthly regulatory reports on field action effectiveness
• Provide status updates to cross-functional teams as needed
• Support audit readiness by providing documentation and updates to audit management
• Assess and manage recall inbox activities, including prioritizing urgent communications
• Develop, maintain, and improve processes within the quality management system
• Collaborate with cross-functional teams to ensure compliance and effective execution of recall activities
  
  

Skills And Qualifications

• Bachelor’s degree in Engineering, Physical or Biological Sciences, or a related technical field
• 4 years of experience in product quality, regulatory compliance, or a related field within a regulated industry
• Knowledge of U.S. medical device regulations (e.g., 21 CFR Part 820, Part 11) and international standards (e.g., ISO 13485, ISO 14971)
• Familiarity with international regulatory requirements (e.g., Canada, Europe, Brazil)
• Understanding of computer-related regulations and compliance methodologies
• Strong organizational, written, and verbal communication skills
• Strong critical thinking and problem-solving abilities
• Ability to prioritize tasks and manage workload in a fast-paced environment
• Strong collaboration skills and ability to work effectively with cross-functional teams
• Ability to communicate effectively and demonstrate appropriate assertiveness
  
  

Preferred Qualifications

• Experience working directly with regulatory agencies such as the FDA, Notified Bodies, or other government entities
  
  

We offer a competitive salary range for this position. Most candidates who join our team are hired at the median of this range, ensuring fair and equitable compensation based on experience and qualifications.

Contractor benefits are available through our 3rd Party Employer of Record (Available upon completion of waiting period for eligible engagements) Benefits include: Medical, Dental, Vision, 401k.

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.