Principal Product Safety & Regulatory Compliance Engineer

Company: Analogic Corporation
Location: Peabody
Posted on: March 10, 2023

Job Description:

Principal Product Safety & Regulatory Compliance Engineer The PS/RC 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.In addition, this position will evaluate, interpret, and communicate emerging or changing global and country/region- specific regulations to Analogic's cross-functional global teams, engaging with industry associations, government representatives and other external stakeholders as needed.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.
• Create, develop, and modify (as necessary) processes that help ensure compliance work is done efficiently, meeting published timelines, milestones and budgets.
• Work hand in hand with our New Product Development (NPD) and Sustaining teams to develop and execute testing as required for regulatory compliance, and to contribute to the on timely launch of products.
• Manage all required reporting to agencies for Analogic's existing products, to maintain compliance in the various countries that may require renewals.
• Provide the reliable execution of documented certification processes to achieve quality, cost, workflow, and on-time product delivery goals.
• Follow all Regulatory submittals through complete process to ensure approvals are received in time for planned production. Intervene where necessary to assure timely, technically correct, approval is received to support product schedule.
• 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 a min of 4+ years of 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 balance technical understanding of products and processes with compliance perspective.
    • 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.
    • Capable of negotiating trade off decisions across the organization.
    • Strong analytical skills and experience implementing risk-based oversight programs.
    • Strong Excel/Spreadsheet analytical skills -Why should you join the Analogic team?At Analogic, we work together to create life-changing technology. We value your unique skills and abilities and invite you to join our team in saving lives by supplying first responders with high-tech medical products and transportation security professionals with leading-edge aviation security screening equipment. We offer great benefits, diverse and passionate team, work-life balance and continuous career advancement. To learn more about our culture, mission and vision please visit www.analogic.com
      • 401k with company match vested immediately
      • HSA/FSA match
      • 8 weeks paid parental leave
      • Healthcare for now and healthcare as your family and health change
      • You will be joining a passionate, driven and diverse global team!Equal Opportunity Employer/Protected Veterans/Individuals with DisabilitiesThe contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information. 41 CFR 60-1.35(c)

Keywords: Analogic Corporation, Peabody , Principal Product Safety & Regulatory Compliance Engineer, Engineering , Peabody, Massachusetts