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Regulatory Compliance Specialist

2 months ago

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

POSITION / JOB SUMMARY:

The Compliance Engineer plays a crucial role in overseeing all technical and engineering documentation for assigned projects. This position is essential for planning and managing technical tasks related to 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, which includes regulatory submissions for FDA and CE Mark, as well as overseeing process validations for sterilization, packaging, and reprocessing. Additionally, this role entails leading cross-functional teams and coordinating external resources while authoring, organizing, and maintaining test plans, protocols, and reports.

Key Responsibilities:

Product Support (50%):

  • Ensure ongoing compliance with US, EU, and global regulatory standards by developing necessary test plans, protocols, and reports to demonstrate conformity.
  • Lead design assurance teams, including engineers focused on Human Factors, Biocompatibility, Packaging, Risk, Sterilization, and Manufacturing throughout product design, re-design, development, design transfer, and Post Market Surveillance (PMS) activities.
  • Oversee sterilization processes to guarantee products are market-ready.
  • Drive the development and validation of testing methods with the testing team, identifying applicable standards and guidance, establishing acceptance criteria, and approving results.
  • Conduct gap analyses of relevant standards to determine necessary actions for maintaining technical documentation and declarations of conformity.
  • Manage the Risk Management process, including writing, editing, and maintaining risk management plans/reports, risk assessments (FMEAs), and hazard analyses.
  • Provide engineering support in troubleshooting manufacturing processes in collaboration with manufacturing partners.

Quality Systems/Design Control Processes (50%):

  • Coordinate, draft, and maintain documentation in support of ISO 13485 and FDA 820 quality systems, including design control documentation such as Design History File (DHF), Device Master Record (DMR), Device History Record (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 root cause analysis for quality and clinical issues arising from current products.

Qualifications:

Required Qualifications:

Education:

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

Experience:

  • 5+ years of relevant experience in a similar capacity 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.
  • Strong 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 creative problem-solving skills and original thinking for compliance solutions.
  • Capability to manage multiple tasks concurrently with shifting 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).
  • Familiarity with biocompatibility standards.
  • Experience in risk management practices.
  • 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.
  • Experience with CE Mark products.

Skills:

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