Regulatory Affairs Specialist

5 hours ago

Palm Harbor, Florida, United States Integer Holdings Corporation Full time

Job Title: Regulatory Affairs Specialist

Job Summary:

We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Integer Holdings Corporation. The successful candidate will be responsible for planning, executing, and providing oversight to regulatory activities necessary to obtain and maintain regulatory approvals within the United States and International markets.

Key Responsibilities:

  • Adhere to Integer's Values and all safety, environmental, security, and quality requirements, including Quality Management Systems (QMS), Safety, Environmental and Security Management Systems, U.S. Food and Drug Administration (FDA) regulations, company policies, and operating procedures.
  • Work independently, receiving minimal guidance, and act as a resource for colleagues with less experience, directing the work of other staff members.
  • Plan, manage, and implement regulatory strategies and product submissions for the US FDA, EU notified body, and other country-specific regulatory bodies, providing strategic input and participating on Product Development teams.
  • Prepare US and International submissions for Medical Devices and work with government agencies and/or distributors to obtain product approval/clearance.
  • Serve as an informational resource for all departments, assist in keeping the company informed of US and International regulatory requirements, and ensure relevant International, ISO, and FDA requirements are met.
  • Recommend changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.
  • Initiate Free Sales Certificate requests and product release authorizations.
  • Support post-market regulatory compliance activities, including review and assessment of change requests to determine the effect of product changes on US and International regulatory strategy and submissions.
  • Evaluate post-market incident reports and determine MDR requirements.
  • Develop and maintain regulatory status documents and submission procedures.
  • Assist with recall/retrieval documentation and other activities.
  • Identify, investigate, evaluate, and implement, as appropriate, new methodologies associated with product quality and quality systems.

Requirements:

  • Minimum Education: Bachelor's Degree in a related field.
  • Minimum Experience: 3 years of US and International medical device, IVD, or pharmaceutical regulatory submission/approval experience, including US FDA, EU MDD/AIMD, and/or EU MDR, Japan PMDA, Australia TGA, and China CDA; or 2 years of experience with Master's in Regulatory Affairs.

Preferred Skills:

  • Ability to research, compile, summarize, and present information.
  • Ability to work through issues with customers.
  • Knowledge of US FDA Quality System Regulations and ISO Requirements.
  • Knowledge of applicable laws that regulate medical device manufacturers.
  • Skill in working with computers and experience with Microsoft Office Suite.

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