Thermo Fisher Scientific Regulatory Affairs Specialist III in Chelmsford, Massachusetts
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.
Supports 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.
Provides review, consultation and support for regulatory agency communications for LPD in North America.
Should have a 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, 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.
Non-Negotiable Hiring Criteria:
Education: B.S./B.A (preferred) in technical related field.
Demonstrated experience working with certification agencies and testing laboratories .
Working knowledge of the applicable safety standards and how to apply them effectively.
Adaptability and flexibility to manage changing demands and handle substantial time pressures
Working 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.
Comfortable 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.
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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.