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Regulatory Specialist

Regulatory Specialist

Ferris Mfg. Corp.Fort Worth, TX, United States
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Location : Fort Worth, TX | Full-Time | On-Site

Ferris Mfg. Corp., a Fort Worth-based medical device manufacturer and creator of PolyMem Advanced Wound Care Dressings, is seeking a Regulatory Specialist to support the Regulatory Development team.

We are seeking a Regulatory Specialist to support product registrations, compliance, and quality systems across multiple departments. This role involves preparing regulatory submissions, supporting audits, monitoring regulatory changes, and collaborating with international partners to ensure product compliance worldwide.

Key Responsibilities

  • Prepare and submit regulatory documents for product registrations.
  • Ensure compliance with local, national, and international regulations.
  • Support internal and external audits.
  • Stay current on regulatory changes and industry standards.
  • Draft and manage CAPAs related to compliance.
  • Collaborate with Manufacturing, Product Development, Marketing, and Sales teams.
  • Provide international partners with documentation for product registrations.
  • Draft, edit, and maintain policies, procedures, technical documents, and records.
  • Assist with product complaint investigations.
  • Work with clinical team to generate PMS, CER, PSUR, and PMCF reports.
  • Monitor regulatory, cultural, and market changes impacting Ferris and its quality system.
  • Conduct gap analyses and support strategy development with management and consultants.

Education / Experience

  • Bachelor’s degree in a related field (e.g., scientific discipline, engineering, pre-law).
  • Minimum 2 years of experience in quality assurance, regulatory affairs, or a related role in the medical device industry.
  • Knowledge of relevant regulatory requirements and quality standards (e.g., ISO 13485, FDA QMSR, 21 CFR, EU MDR, ISO 14001).
  • Strong attention to detail with excellent organizational skills.
  • Effective written and verbal communication skills; strong interpersonal abilities.
  • Ability to work independently as well as collaboratively in a team environment.
  • Proficiency with Microsoft Office Suite and quality management software.
  • Technical writing experience preferred.
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