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Regulatory Affairs Specialist / Product Compliance Specialist
Company: Thermo Fisher Scientific
Location: Asheville, NC
Employment Type: Full Time
Date Posted: 11/07/2020
Expire Date: 02/03/2021
Job Categories: Advertising/Marketing/Public Relations, Computers, Software, Information Technology, Sales, Quality Control, Research & Development, Environmental
Job Description
Regulatory Affairs Specialist / Product Compliance Specialist

When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.

Location/Division Specific Information

This opportunity will be located in Marietta, OH. The role will support 3 Business Units and and the larger Laboratory Products Division (LPD).

How will you make an impact?

By driving the compliance of our legacy products, you will be ensuring that our customers will continue to perform their research, laboratory activities, and substance monitoring of critical water and environmental conditions through uninterrupted access to the WLP and LPD product portfolio. The LPD products are an industry established and diverse portfolio of products that are used by our customers to make the world cleaner, healthier and safer.

What will you do?

  • Responsible for the coordination, evaluation and implementation of LPD’s regulatory strategy and compliance programs through the review, consultation, training and support of each discipline (Engineering, Operations, Quality, Sales, Sourcing etc) to fulfill their business goals in a compliant manner.
  • Responsible for supporting a Regulatory Affairs network of people and resources in North America to provide local general regulatory support in the regions and time zones where LPD facilities operate with additional review and consultation for more detailed regulatory needs from centers of compliance excellence.
  • Liaise between the respective disciplines and 3rd Party regulatory agencies (UL, CSA, TUV, Notified Bodies, FDA, ISO registrars, etc) and ensures this interaction follows the established best practice model for the division.
  • Provides review, consultation and support for regulatory agency communications for LPD in North America.
  • Should have a working knowledge of and eagerness to expand knowledge of the applicable standards and regulations that apply to LPD (product safety standards like IEC 61010-1, EMC standards, etc) to filter and disseminate applicable information to the respective disciplines inside LPD and the regulatory agencies for a consistent compliance approach.
  • Participates in product reviews and ensures that the RA team provides a compliance review of each stage gate review for both internal product designs or changes and OEM branding projects
  • Support and help effectively manage through the RA team any identified non-conformity, product liability or incident.
  • Aids in resolving customer related compliance issues.
  • Act as a change agent for improvement initiatives.
  • Perform all job duties in a safe manner and obey all safety policies and procedures
  • Perform as a Role Model Leader, acting in compliance with the Thermo Fisher Code of Ethics and the 4-I Values (Integrity, Intensity, Involvement and Innovation).
  • Perform all job duties within ISO standards, regulatory or statutory.

How will you get here?

Education: B.S./B.A (preferred) in Engineering or a technical related field.

  • Experience in product compliance or product stewardship 3-5 years either in industry or at a Nationally Recognized Test Labs.
  • Demonstrated experience working with certification agencies and testing laboratories
  • Working knowledge of the applicable safety standards and how to apply them effectively.
  • Familiar with EMC but bonus points if knowledgeable EMC and Wireless requirements.
  • Must have experience in Microsoft office.
  • Nice to have experience with ERP software, such as SAP or BAAN.

Knowledge, Skills, Abilities

  • Excellent Communication – able to communicate, written and oral, with both technical and non-technical colleagues.
  • Self-Motivator – Does not to accept “waiting for a response”. Will work with respective party to obtain the proper response and drive a project forward. Looks for and implements improvement.
  • Problem Solver- Identifies complex problems and reviews related information to develop and evaluate options and implement solutions.
  • Project Management – able to manage parallel projects and sometimes competing deliverables to meet project delivery dates.
  • Passion to help others – Keeping and expanding our products offerings supports our customers who utilize our products to make exceptional discoveries to make the world cleaner, healthier, and safer.

This position has not been approved for Relocation Assistance.

Contact Information
Company Name: Thermo Fisher Scientific
Website: https://thermofisher.contacthr.com/...
Company Description:

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