Senior Compliance Engineer

Analogic • Salem, NH

5h

About The Position

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. This role will enhance delivery of key compliance programs/initiatives by improving submittal and review procedures. It assures compliance to the policies of worldwide regulatory agencies by maintaining knowledge of current and evolving standards and provides training programs and oversight on all relevant regulatory rules and processes. The primary solutions involved are leading-edge aviation security screening equipment, with any FDA related products representing less than 10%.

Requirements

• 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.
• 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

Nice To Haves

• FDA filing experience a plus.
• Knowledge of AGILE PLM a plus.

Responsibilities

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Number of Employees: 501-1,000 employees