Regulatory Compliance Engineer

3 hours ago


Manchester, United Kingdom Merrimack Manufacturing Full time
Job Description:

We are seeking a skilled Regulatory Compliance Engineer to join our team at Merrimack Manufacturing. This role will involve ensuring compliance with applicable regulatory standards throughout the New Product Introduction process and supporting design transfer activities.

Main Responsibilities:
  • Evaluate new products, manufacturing processes, and ensure compliance with applicable regulatory standards throughout the New Product Introduction process.
  • Generate and maintain control plans, risk management files, validation protocols, and other QMS documentation to support initial qualification and launch of commercial production activity.
  • Lead project teams through protocol generation, execution, documentation organization, report writing, etc. while meeting schedule for final approval and release for use.
Requirements:
  • Bachelor's degree in a relevant technical field; equivalent experience will be considered.
  • At least 3 years of experience in Medical Device Manufacturing or a similarly regulated industry.
  • Strong knowledge of CFR Part 820 and ISO 13485 required.
  • Estimated Salary: $80,000 - $110,000 per year.


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