Regulatory Affairs Specialist

4 days ago

Gardner, Massachusetts, United States Precision Optics Corporation Inc Full time

Precision Optics Corporation Inc is seeking a Regulatory Affairs Specialist to join our team. In this role, you will be responsible for ensuring our products comply with relevant regulations and standards. Your expertise in export compliance, ITAR regulations, and quality management will drive business growth and improve operational efficiency.

Key Responsibilities:
  • Develop and implement quality and regulatory strategies, policies, programs, and procedures
  • Ensure compliance with US FDA, ISO, ITAR, and other applicable regulations
  • Manage export compliance activities, including DSP-5s, TAAs, MLAs, and EAR SNAP-R applications
  • Partner with engineers and program managers to determine jurisdiction and classification of products and technical data

The ideal candidate has 8-10 years of experience in quality assurance and regulatory affairs, preferably in process-oriented manufacturing operations in a regulated environment. A Bachelor's degree in engineering or a related technical field is required, with a Master's degree preferred. Strong leadership skills, attention to detail, and analytical problem-solving abilities are essential for this role. Estimated salary: $110,000 - $140,000 per year.

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