Sr Regulatory Affairs Specialist

H.B. Fuller-posted 3 months ago
$90,000 - $115,000/Yr
Full-time • Mid Level
Hudson, NC
5,001-10,000 employees
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H.B. Fuller is seeking a highly skilled and detail-oriented Senior Regulatory Affairs Specialist to support our global regulatory objectives. This individual will play a critical role in ensuring our medical devices comply with regulatory requirements and standards across multiple markets. The position involves preparing and managing submissions, maintaining compliance with global regulations, and collaborating cross-functionally to support product development and lifecycle management.

  • Prepare, review, and submit regulatory documents including FDA 510(k), PMA, De Novo, pre-submissions and EU MDR technical files.
  • Develop regulatory strategies for new products and modifications.
  • Monitor submission status and communicate updates to stakeholders.
  • Serve as primary contact for FDA (CDRH), Health Canada, EU Notified Bodies, TGA, PMDA, and others.
  • Manage regulatory meetings, audits, and inspections.
  • Respond to agency inquiries with complete and timely information.
  • Ensure compliance with FDA 21 CFR Parts 820 & 11, EU MDR (2017/745), ISO 13485:2016, MDSAP and other country-specific regulations.
  • Maintain global regulatory documentation and licenses.
  • Ensure labeling and packaging meet global UDI requirements, FDA GUDID, EU MDR UDI, GS1 GTIN, UBICC.
  • Collaborate with Supply Chain and Labeling teams for accurate product identification.
  • Partner with R&D, QA, Supply Chain, Marketing, and Clinical Affairs.
  • Support audits and inspections.
  • Mentor junior regulatory staff and contribute to team development.
  • Bachelor’s degree in Life Sciences, Engineering, Regulatory Affairs, or related field.
  • 5 years of Regulatory Affairs experience in the medical device industry.
  • Experience with FDA and international submissions.
  • Hands-on experience with UDI, GTIN, UBICC systems.
  • Familiarity with Class II and III medical devices.
  • Fluent in English.
  • RAC certification.
  • Deep understanding of FDA, EU MDR, ISO 13485, and global standards.
  • Strong written and verbal communication skills.
  • High attention to detail and ability to manage multiple deadlines.
  • Proficient in Microsoft Office and regulatory submission tools.
  • Experience with eQMS systems and Quality Assurance.
  • Prior experience with single-use medical devices.
  • Ability to travel up to 10% for regulatory meetings and audits.
  • Comprehensive benefits package.
  • Incentive and recognition programs.
  • Health & wellness benefits.
  • 401K contributions.
  • Paid time off and paid holidays.
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