Element Materials Technology

Senior Regulatory Project Manager

Job Locations US-OH-Fairfield
ID
2021-6624

Overview

Element has an opportunity for a Senior Regulatory Lead to join our rapidly expanding team. As a member of the operations team, the Senior Regulatory Lead to engage with our testing customers and provide regulatory support ranging from pre-submissions, to FDA and other regulatory body responses, and full regulatory submission ownership.

 

Responsibilities

  • Provides regulatory guidance and direction as the senior regulatory affairs project lead, supporting external customers with regulatory projects throughout the product development life-cycle
  • Prepare, organize, author, evaluate, and submit high-quality regulatory FDA 510(k) submissions or equivalent and responses for clients on time and on/under budget
  • Develops and implements regulatory strategies for new and modified products and regulatory processes, and prepares submissions to obtain and maintain global regulatory approvals of products in line with industry guidance and standards
  • Acts as company representative, developing and maintaining positive relationships with regulatory agency reviewers through oral and written communications regarding pre-submission strategy/regulatory pathway development, testing requirements, clarification and follow up of submissions under review
  • Generates and reviews technical documentation and the writing and compilation of technical files
  • Develops and maintains professional relationships with new and existing clients
  • Review regulatory documentation to ensure completeness, clarity and conformance Prepares for and assists with Notified Body technical audits; responds to any deficiencies
  • Coordinate, lead, and/or participate in client and/or regulatory meetings
  • Interact with auditors, inspectors, subcontractors, and regulatory personnel to move projects to completion
  • Engage with Elements technical experts to drive solutions for regulatory questions and issues
  • Author and/or evaluate client test protocols
  • Author and/or review technical white papers, articles, and other marketing content
  • Maintain and increase knowledge and understanding of current regulatory guidance, policies, and industry standards
  • Communicate and work with internal teams to provide regulatory guidance on client projects and questions as needed
  • Create the framework for a regulatory team dependent on growth

Skills / Qualifications

  • Must have demonstrated multiple 510(k) or equivalent regulatory submissions from start to finish
  • Experience in orthopedics is a requirement – primarily spine, hip, knees, shoulders, etc.
  • Ability to review, understand, and interpret regulatory and technical documentation, policies, and procedures in regard to client projects and regulatory approach
  • Ability to clearly communicate the information above to clients, internal teams, and regulatory personnel
  • Self-starter and leadership ability. Position will be heavily relied on to create new processes, procedures, and create the framework for a regulatory team
  • Ability to manage projects from beginning to end while maintaining internal/external communication and achieving agreed-upon milestones
  • Minimum 10 years in medical device regulatory space
  • MS in Biomedical Engineering (or equivalent). PhD preferred
  • Fluency in English. Other languages are a bonus

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Company Overview

We are Element, one of the fastest growing testing, inspection, certification and calibration businesses in the world.

 

We deliver critical services in Materials Testing, Product Qualification Testing, Certification, Device Calibration and Advisory Services to the Aerospace, Oil and Gas, Transportation, Industrials, Fire and Building product, Infrastructure and other leading sectors, where failure in service is simply not an option.

 

Everything we do helps our customers to build better products; get their products to market on time; save them time and money; and minimize the risk associated with product development and production.

 

Our mission is simple: to be the best testing partner in the world and together we strive towards a common vision of becoming the world’s most trusted testing partner.

 

We have four values that we strive to live by every single day.

  • Safety - We keep our colleagues and visitors safe
  • Integrity - We act honestly and fairly to do the right thing
  • Excellence - We set new standards of excellence in everything we do
  • Partnership - We work together for the benefit of our customers

When combined with our mission and vision, the ethos this creates, enables Element to deliver one thing. CERTAINTY.  We exist to help make certain that the materials and products we test, inspect, certify and calibrate for our customers are safe, quality, compliant and fit for purpose.

Diversity Statement

At Element, we always take pride in putting our people first. We are an equal opportunity employer that recognizes diversity and inclusion as fundamental to our Vision of becoming “the world’s most trusted testing partner”.

 

All suitably qualified candidates will receive consideration for employment on the basis of objective work related criteria and without regard for the following: race, colour, age, religion, gender, national origin, disability, and/or protected veteran status, or other characteristics in accordance with the applicable governing laws.

TIC Council Statement

Element is proud to be a full member of the Testing, Inspection & Certification Council (the “TIC Council”), an international association representing independent testing, inspection and certification companies. 

 

Members of the TIC Council must implement and abide by the TIC Council Compliance Code. Element has therefore issued an overarching Code of Conduct which is supported by our Compliance Programme. A copy of the Code of Conduct and more information about our Compliance Programme can be found in the Governance and Integrity section of www.element.com

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