Our client, a Medical Technology company, is looking for a Compliance Specialist 2 for their Sunnyvale, CA/Hybrid location.
Responsibilities:
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 field action team to ensure that appropriate processing of customer acknowledgement forms and inquiries related to field actions.
Collaboration with business partners, field action team, and management to address customer escalation concerns as it related to field action.
They will have strong organization and communications 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
Processing and reconciling customer returned acknowledgement forms per regulations and internal procedures.
Provides 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.
Assists with providing information to Audit Management on maintaining audit readiness for internal and external audits.
Performs assessments, develops action plans, and drives plan to effectively manage recall inbox and address any urgent communication appropriately.
Collaborate in development, maintenance, and improve processes and procedures for various processes within the quality management system and where necessary.
Requirements:
Minimum Bachelor Degree – BS degree in Engineering, Physical or Biological Science, or other technical field
Minimum 4 plus years’ experience in product quality or regulatory compliance (or combined experience) in the medical device or other regulated industry.
Has 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; plus critical thinking skills and proficient in constructive dialogue
Effective at prioritizing tasks and responsibilities within a fast-paced, dynamic environment
Effective in collaborating and partnering with field action team and displaying an appropriate level of assertiveness
Experience working directly with the FDA, Notified Body, or other governmental agencies (preferred)