Regulatory Compliance Specialist

2 weeks ago

Saint Paul, Minnesota, United States Scanlan Int'l Full time
Job Overview

POSITION / JOB SUMMARY:

The Compliance Engineer at Scanlan Int'l plays a crucial role in overseeing all technical and engineering documentation related to assigned projects. This position involves planning and managing technical tasks for Single-Use Devices and Re-Usable Surgical Instruments, ensuring precision and quality throughout the product lifecycle. The Compliance Engineer will maintain comprehensive technical documentation for global distribution, including compliance with FDA and CE Mark regulations, as well as uphold process validations for sterilization, packaging, and reprocessing. Additionally, this role encompasses leading cross-functional teams and coordinating external resources while authoring, organizing, and maintaining test plans, protocols, and reports.

Key Responsibilities:

Product Support (50%):

  • Ensure that products comply with regulatory requirements across the US, EU, and other regions by developing necessary test plans, protocols, and reports to demonstrate conformity.
  • Lead design assurance teams, including engineers specializing in Human Factors, Biocompatibility, Packaging, Risk, Sterilization, and Manufacturing throughout product design, redesign, development, design transfer, and Post Market Surveillance (PMS) activities.
  • Oversee sterilization processes to guarantee that products are ready for market release.
  • Drive the development and validation of testing methods in collaboration with the testing group, including identifying applicable standards and guidelines, establishing acceptance criteria, and approving results.
  • Conduct gap analyses of relevant standards to identify necessary actions for maintaining technical documentation and declarations of conformity.
  • Manage the Risk Management process by writing, editing, and maintaining risk management plans/reports, risk assessments (FMEAs), and hazard analyses.
  • Provide engineering support to troubleshoot manufacturing processes in collaboration with manufacturing partners.

Quality Systems/Design Control Processes (50%):

  • Coordinate, draft, and maintain documentation to support ISO 13485 and FDA 820 quality systems, including design control documentation such as Design History Files (DHF), Device Master Records (DMR), Device History Records (DHR), Technical Construction Files (TCF), Work Instructions (WI), Manufacturing Procedures (MP), and Bill of Materials (BOM).
  • Investigate product complaints and engage in the Corrective Actions/Preventative Action process.
  • Facilitate the identification of root causes for quality and clinical issues that arise with current products.

Qualifications:

Required Qualifications:

Education:

  • Bachelor's degree in Engineering, Sciences, or a related field.

Experience:

  • Minimum of 5 years of relevant experience in a similar role within a regulated industry (e.g., medical device, pharmaceutical, aerospace), including experience with quality management systems (QMS).
  • Experience in technical review and documentation updates to ensure compliance with quality system requirements.
  • Proven ability to understand and interpret regulations, standards, and laws in a regulated environment.

Skills:

  • Proficient in MS Office Suite (Word, Excel, Outlook, OneNote) and MS Project.
  • Excellent verbal and written communication skills, with the ability to effectively engage at various organizational levels.
  • Ability to influence and lead indirectly, even in challenging situations.
  • Self-directed with a strong sense of appropriate review and approvals.
  • Demonstrated creativity and effectiveness in problem-solving and developing compliance solutions.
  • Capable of managing multiple tasks simultaneously while adapting to changing priorities.

Preferred Qualifications:

Experience:

  • Experience with single-use device packaging and sterilization (gamma and ETO) maintenance and validations.
  • Experience with re-usable device reprocessing (cleaning, thermal disinfection, steam sterilization).
  • Experience with biocompatibility.
  • Experience with risk management.
  • Knowledge of materials and processes such as stainless steel, titanium, nitinol, thermal plastics, and silicone, including extrusion, molding, machining, forging, heat treating, plating, welding, passivation, and electro-polishing.
  • Familiarity with CE Mark products.

Skills:

  • Ability to apply statistical methods and tools, including determining sample sizes, establishing confidence and reliability levels, and developing capability and/or process validation plans with statistically sound sample sizes and analyses.

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