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Regulatory Compliance Office

3 months ago

Houston, United States Pantaq Full time

Pantaq Inc. is seeking a highly skilled and experienced Regulatory Compliance Officer to lead our efforts in obtaining FDA certification for our company and products. The ideal candidate will have a deep understanding of regulatory requirements, a proven track record in navigating the FDA certification process, and the ability to implement Standard Operating Procedures (SOPs) for all relevant operations. This role is critical to ensuring our products meet all regulatory standards, allowing us to bring our innovative solutions to market.

Key Responsibilities:

  • Lead Regulatory Compliance Efforts: Develop and implement regulatory strategies to ensure compliance with FDA regulations. Prepare and submit FDA applications for product approvals, including 510(k), PMA, and other regulatory submissions.
  • Documentation and Reporting: Maintain up-to-date knowledge of FDA regulations and guidelines. Ensure all regulatory documentation is accurate, complete, and submitted on time. Prepare and manage all necessary documentation, including technical files, regulatory submissions, and compliance reports.
  • Cross-Functional Collaboration: Work closely with product development, quality assurance, and other teams to ensure regulatory requirements are met throughout the product lifecycle. Provide regulatory guidance and training to internal teams to ensure compliance with FDA regulations.
  • Regulatory Audits and Inspections: Lead and manage regulatory audits and inspections by FDA and other regulatory bodies. Develop and implement corrective action plans to address any findings from regulatory inspections.
  • Implement SOPs: Develop, implement, and maintain Standard Operating Procedures (SOPs) for all relevant business operations. Ensure SOPs are aligned with regulatory requirements and best practices. Train and guide staff on adherence to SOPs to ensure consistency and compliance across the organization.

Qualifications:

  • Bachelor's degree in Regulatory Affairs, Life Sciences, Engineering, or a related field (advanced degree preferred).
  • Minimum of 5 years of experience in regulatory affairs, with a focus on FDA certification and compliance.
  • In-depth knowledge of FDA regulations, including 21 CFR Part 820, 510(k), PMA, and other relevant guidelines.
  • Proven experience in preparing and submitting FDA regulatory submissions.
  • Experience in developing and implementing SOPs.
  • Strong analytical and problem-solving skills, with the ability to interpret and apply regulatory requirements.
  • Excellent written and verbal communication skills, with the ability to clearly articulate regulatory requirements to cross-functional teams.
  • Detail-oriented with strong organizational and project management skills.
  • Ability to work independently and as part of a team in a fast-paced environment.

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