Thermo Fisher Scientific Sr. Regulatory Affairs Specialist in Remote / Field, Massachusetts

Job Description

Job Title : Sr. Regulatory Affairs Specialist

Requisition ID: 71424BR

Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with revenues of more than $20 billion and approximately 65,000 employees globally. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics, deliver medicines to market and increase laboratory productivity. Through our premier brands – Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific and Unity Lab Services – we offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive services.

Position Summary and Key Responsibilities

This position is a divisional role and one of the Regulatory Affairs core team members supporting North America and OEM, for the Laboratory Products Division (LPD). The North American arm of the Regulatory Affairs core team for LPD is responsible for facilitating and executing regulatory strategy defined by the LPD Director of Regulatory Affairs. This position assists customers by providing regulatory guidance and support as it applies to the use of LPD’s products and services. This position will interact with the OEM Customer’s Regulatory Affairs representatives applicable to the region to support Global submissions and resolve regulatory issues. In addition, this position will ensure adherence to established processes, policies and procedures of the company and external regulatory agencies.

Key Responsibilities:

  • 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.

  • Drives an effective interface 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.

  • Drives review, consultation and support for regulatory agency communications for LED in North America (e.g. FDA, EU Competent Authorities, China SFDA, etc.).

  • Should have a strong working knowledge of and eager to expand knowledge of the applicable standards and regulations that apply to LPD (product safety standards like IEC 61010-1, EMC standards, applicable regulations like the RoHS, REACH and the F-gas regulation etc.) so that that RA team can disseminate and filter this information to the respective disciplines inside LPD and the regulatory agencies that LPD works with to establish 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.

  • Assist in the responsibility for reducing product liability while driving towards achieving our 20:20 vision of world class product compliance by 2020.

  • Must support and help effectively manage through the RA team any identified non-conformity or product liability discovery or incident.

  • Provides support to customers relative to 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 requirements.

Minimum Qualifications : Non-Negotiable Hiring Criteria

  • Education: B.S. or B.A in technical or business related field.

  • Demonstrated experience with certification agency testing ranging from instrumentation to new product design data package submission.

  • Working knowledge of the applicable safety standards and how to apply them effectively.

  • Working experience or qualified under safety certification agency data acceptance program such as UL’s Data Acceptance Program (DAP) or CSA’s category program for certification (CPC).

  • Adaptability and flexibility to manage changing demands and handle substantial time pressures

  • Solid knowledge in problem solving, particularly around managing a new regulation requirement, or risk assessment around a product liability issue.

  • Position requires up to 20% overnight and international travel. Required travel may span weekend days and/or holidays. Must have or be able to obtain a valid passport which allows travel to countries in Europe with occasional travel to S. America and Asia Pacific as required. Requires ability to transport and use common computer and communications equipment while traveling.

  • Job duties may require brief exposure to research laboratory biopharmaceutical or pharmaceutical laboratory equipment.

  • Effective working with interdisciplinary teams and effectively coordinates and where appropriate leads efforts from various internal functional groups, which will result in collective team achievements.

This position (has not) been approved for Relocation Assistance.

At Thermo Fisher Scientific, each one of our 65,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer. Apply today http://jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.