What are the responsibilities and job description for the Compliance Specialist position at SMARTFOX?
Job Title: Compliance Specialist
Duration: 6 months
Onsite/Hybrid/Remote: Set Schedule, Minimum 3 Days Per Week
Location: Sunnyvale, CA 94086
Pay rate: $23/hr. on W2
Mode of interview: Zoom
No of rounds of interview: 2
Skills
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)
Education
Minimum Bachelor Degree BS degree in Engineering, Physical or Biological Science, or other technical field
Duration: 6 months
Onsite/Hybrid/Remote: Set Schedule, Minimum 3 Days Per Week
Location: Sunnyvale, CA 94086
Pay rate: $23/hr. on W2
Mode of interview: Zoom
No of rounds of interview: 2
Skills
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)
Education
Minimum Bachelor Degree BS degree in Engineering, Physical or Biological Science, or other technical field
Salary : $23