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Regulatory Compliance Specialist

2 months ago

Cleveland, Ohio, United States ACE Partners Full time

Regulatory Compliance Specialist

Salary Range: $90,000 - $110,000

Work Environment: On Site

Industry: Medical Device

Position Overview:

We are seeking a skilled Regulatory Compliance Specialist with over 5 years of experience in the medical device sector. This role is crucial in ensuring that our products adhere to all necessary regulatory standards and guidelines.

Key Responsibilities:

  • Ensure compliance of devices with FDA, ISO, and global regulations.
  • Prepare and submit documentation for 510(k), PMA, and CE marking.
  • Formulate strategies to expedite product approval processes.
  • Enhance and maintain Quality Management Systems in accordance with ISO 13485.
  • Review and approve product labeling and promotional materials.
  • Lead both internal and external compliance audits.
  • Conduct comprehensive risk assessments and develop mitigation strategies.
  • Collaborate with Research & Development, Quality Assurance, and Manufacturing teams.

Required Qualifications:

  • Bachelor's degree in Life Sciences, Engineering, or a related field.
  • A minimum of 5 years of experience in regulatory affairs within the medical device industry.
  • In-depth knowledge of FDA regulations and ISO 13485 standards.
  • Strong skills in preparing regulatory documentation.
  • Exceptional verbal and written communication abilities.
  • High attention to detail in documentation processes.

Benefits Offered:

  • Competitive salary: $90,000 - $120,000
  • Comprehensive health, dental, and vision insurance
  • 401(k) plan with company matching
  • Generous paid time off and holiday schedule
  • Opportunities for professional growth and development