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Compliance Specialist

eTeam Inc.

Sunnyvale, CA

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JOB DETAILS
SALARY
$24–$25 Per Hour
SKILLS
Address Management, Auditing, Biology, Code of Federal Regulations, Communication Skills, Computer Skills, Cross-Functional, Customer Escalations, Customer Relations, Customer Support/Service, Establish Priorities, External Audit, FDA (Food and Drug Administration), ISO (International Organization for Standardization), Internal Audit, Medical Equipment, Organizational Skills, People Management, Physical Science, Presentation/Verbal Skills, Procedure Development, Process Improvement, Quality Assurance, Quality Management, Regulations, Regulatory Compliance, Regulatory Reports, Writing Skills
LOCATION
Sunnyvale, CA
POSTED
30+ days ago
Job Title: Compliance Specialist 3
Duration: 6 months
Location: Sunnyvale, CA (Min 3 days/week onsite)

Primary Function of Position
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.

Essential Job Duties
  • 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.
  • 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.
Preferred Skills and Experience
  • 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)

About the Company

e

eTeam Inc.

Looking for a great job? Join eTeam. We’re looking for talented staffing professionals to join our staff. We also provide contract assignments and full-time jobs at Fortune 2000 Companies. We’ve been named one of the best companies to work for by Staffing Industry Analysts and New Jersey Business.
COMPANY SIZE
100 to 499 employees
INDUSTRY
Other/Not Classified
FOUNDED
1998
WEBSITE
www.eteaminc.com

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