Senior Compliance Engineer

SUMMARY:

The Principal Compliance Engineer will be responsible for achieving required product safety and regulatory compliance for products manufactured and sold by the Analogic Corporation and its subsidiaries. Enhance delivery of key compliance programs/initiatives by improving submittal and review procedures. Assures compliance to the policies of worldwide regulatory agencies by maintaining knowledge of current and evolving standards. Provide training programs and oversight on all relevant regulatory rules and processes.

The primary solutions you will be involved in are our leading-edge aviation security screening equipment - any FDA related products will represent less than 10%.

DUTIES:

• Serve as an experienced regulatory compliance advisor and authority on key strategic and critical compliance issues. Provide guidance to product line compliance engineers, product managers and engineering staff.
• Lead Problem solving activities (independently and as a team) on critical Product safety/Regulatory compliance investigations.
• Stay current on applicable Standards and Regulations and communicate these across the organization as required, including advising how they impact Analogic's products and costs.
• Oversee processes to ensure compliance work is done efficiently, meeting published timelines, milestones and budgets.
• Support New Product Development (NPD) and Sustaining teams to develop and execute testing as required for maintaining regulatory compliance.
• Manage all required reporting to agencies for Analogic's existing products, to maintain compliance in the various countries that may require renewals.
• Follow all Regulatory submittals through complete process to ensure approvals are received in time for planned production.
• Prepare appropriate documentation and sample submission packages. Initiate and manage NRTL (National Recognized Test Laboratory) projects. Examples of NRTL's include UL, CSA, TUV and more.

EDUCATION AND EXPERIENCE:

• BS degree in a technical discipline, and 7-10 years of direct experience leading various aspects of global Safety Regulatory and Compliance processes.
• Knowledge of regulatory requirements/product safety certification processes e.g., NTRL / UL standards and testing requirements.
• Knowledge of product CE Mark and declarations needed, FDA filing experience a plus.
• Knowledge of AGILE PLM a plus.

ADDITIONAL SKILLS:

• Ability to perform in a multifunctional-team-work environment and be able to work independently

• Skills to work well with regulators regarding including inspection activities/outcomes, field actions, and other compliance issues.

• Strong analytical skills and experience implementing risk-based oversight programs.

• Strong Excel/Spreadsheet analytical skills

What We Offer

We appreciate that our employees work diligently to contribute to our success as an organization. We also recognize the importance of work-life balance and therefore developed a competitive total rewards package including programs that offer employees flexibility to balance their work and life including:

• 9/80 work schedule - enjoy every other Friday off!
• Flexible Vacation - employees can take time off as is reasonably needed
• Comprehensive benefits including medical, dental, vision, life insurance and disability plans.
• HRA (for PPO plan participants) /HSA (Health Savings Account for high deductible plan participants) contribution
• 401K with company match and immediate vesting
• Continuous Education Assistance
• Supportive culture that values innovation, collaboration, and excellence