Regulatory Affairs Specialist

2 days ago

Orlando, Florida, United States Mastech Digital Full time
Senior Regulatory Affairs Specialist

Mastech Digital is seeking a highly skilled Senior Regulatory Affairs Specialist to join our team. As a key member of our regulatory team, you will be responsible for ensuring compliance with regulatory requirements and laws.

Key Responsibilities:
  • Regulatory Submissions: Prepare and compile document packages for regulatory submissions, audits, and inspections.
  • Technical Review: Participate in the technical review of data or reports that will be incorporated into regulatory submissions.
  • Database Management: Manage and maintain regulatory databases and technical files.
  • Audits and Investigations: Participate in internal and external audits and investigations.
  • Regulatory Compliance: Review materials such as labeling, marketing materials, or user manuals to ensure compliance with regulatory agency requirements and laws.
  • Labeling and UDI: Manage labeling and unique device identification requirements.
  • Regulatory Support: Provide high-level regulatory support on projects and cross-functional teams.
  • Process Improvement: Contribute to developing or improving processes, procedures, and standards that contribute to meeting internal SOPs, regulatory, and industry regulations.
Requirements:
  • Communication Skills: Excellent communication, including verbal, technical writing, interpersonal, and presentation skills.
  • Technical Skills: Proficient with technology applications such as MS Office.
  • Experience: Experience with the creation of technical files and documentation.
  • Regulatory Knowledge: Knowledge of ISO 13485, ISO 14971, ISO 9001, FDA, and foreign regulatory requirements.
  • Data Analysis: Strong data and statistical analysis skills and ability to use data to make informed recommendations.
  • Attention to Detail: High degree of attention to detail.

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