Medical Device Compliance Specialist

Embla Medical

Irvine (CA)

On-site

USD 61,000 - 95,000

Full time

14 days+

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Benefits offered by this job

Medical, Dental, Vision Benefits
401(k) Retirement Plan with employer-m
Bonus potential

Job summary

Embla Medical is seeking a Compliance Specialist to assist the Director of Compliance in managing the Americas compliance program across Embla Medical’s business units. This role includes auditing, reporting, training coordination and ensuring adherence to state and federal regulations related to medical devices and the company code of conduct.

The position requires building a culture of ethical conduct, handling confidential information with discretion, and collaborating with business leaders

Qualifications

  • Experience with risk assessment, controls development, training, monitoring and reporting.
  • Knowledge of state and federal medical device laws and regulations.
  • Ability to handle confidential information with discretion.
  • Strong analytical and communication skills.
  • Preferred: Bachelor's degree in a related field and 2–4 years in healthcare compliance.

Responsibilities

  • Support administration and improvement of the Americas compliance program.
  • Audit and monitor activities across Americas units, track findings and assist action plans.
  • Manage compliance systems and platforms, including transparency reporting.
  • Coordinate compliance training and track completions.
  • Promote ethical conduct and compliance culture.

Skills

Risk assessment
Controls development
Training & monitoring
Data analysis
Discretion
Communication skills
Team collaboration

Education

Bachelor's degree in a related field

Job description

Embla Medical is seeking a Compliance Specialist to assist the Director of Compliance in managing the Americas compliance program across Embla Medical’s business units. This role includes auditing, reporting, training coordination and ensuring adherence to state and federal regulations related to medical devices and the company code of conduct.

The position requires building a culture of ethical conduct, handling confidential information with discretion, and collaborating with business leaders

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