Regulatory Compliance Specialist III

Plano, TX 75074

Posted: 10/24/2025 Job Number: 22085

Job Description

Regulatory Affairs Level III (Senior Specialist) Job Summary: Responsible for global product registrations and regulatory compliance across the design, manufacturing, and commercialization of medical devices, including Class I & II devices, software as a medical device (SaMD), and de novo devices. Oversees regulatory approvals, maintains compliance with applicable standards, and supports Quality Management System (QMS) initiatives to ensure product and process adherence to regulatory requirements.
Key Responsibilities Regulatory Submissions & Compliance
  • Develop and execute regulatory strategies to achieve market clearance efficiently.
  • Prepare, submit, and maintain product registrations, certifications, and approvals to meet U.S., EU, and international requirements. O Prepare 510(k) and/or De Novo submissions for FDA. O Develop technical documentation to ensure EU MDR compliance. O Manage international product registration activities aligned with business objectives.
  • Provide regulatory input for product labeling and marketing materials.
  • Monitor new and evolving regulatory requirements;communicate business impacts.
  • Lead or support Corrective and Preventive Action (CAPA) activities. Product Development Support
  • Provide regulatory input throughout the product lifecycle, including during design control phases.
  • Partner with cross-functional teams to support timely and compliant regulatory submissions. Change Control Management
  • Evaluate and document regulatory impacts of design, manufacturing, and process changes.
  • Ensure updates to product registrations reflect design modifications and QMS changes. Audits & Inspections
  • Support internal and external audits, including participation in FDA and notified body inspections.
  • Prepare regulatory documentation and responses as required.

QMS & Continuous Improvement
  • Complete required QMS and compliance training.
  • Provide regulatory expertise to continuous improvement, Lean, and Kaizen initiatives.
  • Comply with all company policies and procedures.
  • Perform additional duties as assigned.

Qualifications Education
  • Bachelor of Science degree required. Experience
  • 5–7 years of regulatory affairs experience in the medical device industry (respiratory device experience preferred).
  • Proven success leading multiple 510(k) clearances and CE marking projects.
  • Experience with global regulatory submissions and pathways preferred. Technical Skills
  • Strong understanding of the medical device product lifecycle and related regulatory requirements.
  • In-depth knowledge of ISO 13485, FDA 21 CFR Part 820, and EU MDR.
  • Familiarity with ISO 14971 risk management.
  • Proficiency in database systems and advanced Microsoft Excel.
  • Knowledge of continuous improvement methodologies. Personal Attributes
  • Exceptional written and verbal communication skills;able to explain complex regulatory concepts clearly.
  • Analytical and critical thinker with strong problem-solving and decision-making abilities.
  • Highly detail-oriented and accurate in preparing regulatory documentation.

Job Requirements

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Spencer Fuller

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About Plano, TX

Looking for exciting job opportunities in the Plano, Texas area? Discover your next career move in this vibrant city nestled in the heart of the Lone Star State. Plano offers a perfect blend of urban conveniences and natural beauty, with a booming economy and a welcoming community. With renowned companies calling Plano home, including Toyota and Liberty Mutual, endless growth opportunities await. Explore the thriving arts scene at the ArtCentre of Plano, catch a live performance at the Courtyard Theater, or indulge in the unique flavors of Tex-Mex cuisine at local eateries. With easy access to parks like Arbor Hills Nature Preserve and exciting attractions like Legacy West, Plano gives you a perfect work-life balance. Join us in Plano and unlock a world of possibilities for your career!